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 |