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100   $a20090508d2007      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aBundling multiple devices or multiple indications in a single submission$b[electronic resource]
210  1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health :$cCenter for Biologics Evaluation and Research,$d[2007]
215   $a14 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on May 8, 2009).
300   $a"Document issued on: June 22, 2007".
517 1 $aGuidance for industry and FDA staff
606   $aMedical instruments and apparatus$zUnited States$xEvaluation
606   $aUser charges$zUnited States
615  0$aMedical instruments and apparatus$xEvaluation.
615  0$aUser charges
712 02$aCenter for Devices and Radiological Health (U.S.)
712 02$aCenter for Biologics Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910698876103321
996   $aBundling multiple devices or multiple indications in a single submission$93176552
997   $aUNINA