NON-ABSORBABLE SUTURES NYLON

FDA Premarket Approval N83511 S008

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.

Pre-market Approval Supplement Details

DeviceNON-ABSORBABLE SUTURES NYLON
Generic NameSuture, Nonabsorbable, Synthetic, Polyamide
ApplicantDAVIS & GECK, INC.
Date Received1986-12-05
Decision Date1987-02-20
PMAN83511
SupplementS008
Product CodeGAR 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DAVIS & GECK, INC. 1 Casper St. danbury, CT 06810

Supplemental Filings

Supplement NumberDateSupplement Type
N83511Original Filing
S010 1987-04-14 Normal 180 Day Track
S009 1986-12-05 Normal 180 Day Track
S008 1986-12-05 Normal 180 Day Track
S007 1986-10-02 Normal 180 Day Track
S006 1986-07-01 Normal 180 Day Track
S005 1982-12-29
S004 1981-12-15
S003
S002 1981-08-26
S001 1980-12-16

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