The following data is part of a premarket notification filed by Demetech Corp. with the FDA for Demequicktm (rapid Absorbable) Synthetic Surgical Suture.
| Device ID | K123940 |
| 510k Number | K123940 |
| Device Name: | DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | DEMETECH CORP. 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
| Contact | John O'brien |
| Correspondent | John O'brien DEMETECH CORP. 445 APOLLO BEACH BLVD 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 | 2012-12-20 |
| Decision Date | 2014-05-30 |
| Summary: | summary |