The following data is part of a premarket notification filed by Demetech Corp. with the FDA for Demetech Sterile Synthetic Absorbable Sutures (pga) And Needles.
Device ID | K043539 |
510k Number | K043539 |
Device Name: | DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | DEMETECH CORP. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
Contact | Arthur Ward |
Correspondent | Arthur Ward DEMETECH CORP. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-12-22 |
Decision Date | 2005-04-06 |
Summary: | summary |