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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNONABSORBABLE SURG. SUTURES, BRAIDED SILK
Generic NameSuture, nonabsorbable, silk
Regulation Number878.5030
ApplicantDeknatel, Inc.
600 Airport Rd.
Fall River, MA 02720
PMA NumberN84348
Supplement NumberS003
Date Received09/18/1987
Decision Date02/22/1988
Product Code GAP 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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