The following data is part of a premarket notification filed by Demetech Corp. with the FDA for Demecaprone (poliglecaprone 25) Synthetic Monofilament (pgcl) Absorbable Suture.
Device ID | K130083 |
510k Number | K130083 |
Device Name: | DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | DEMETECH CORP. 14175 NW 60th Ave Miami Lakes, FL 33014 |
Contact | Anthony J Dimercurio |
Correspondent | Anthony J Dimercurio DEMETECH CORP. 14175 NW 60th Ave Miami Lakes, FL 33014 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-14 |
Decision Date | 2013-07-17 |
Summary: | summary |