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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.
 
DeviceCHROMIC GUT SUTURE
Generic NameSuture, absorbable, natural
Regulation Number878.4830
ApplicantDeknatel, Inc.
600 Airport Rd.
Fall River, MA 02720
PMA NumberN84381
Supplement NumberS008
Date Received03/31/1988
Decision Date04/28/1988
Product Code GAL 
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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