The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Polysyn Surgical Suture.
| Device ID | K141625 |
| 510k Number | K141625 |
| Device Name: | POLYSYN SURGICAL SUTURE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Contact | Paul Amudala |
| Correspondent | Paul Amudala SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-17 |
| Decision Date | 2014-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782015815 | K141625 | 000 |
| 10848782015402 | K141625 | 000 |
| 10848782015457 | K141625 | 000 |
| 10848782015471 | K141625 | 000 |
| 10848782015488 | K141625 | 000 |
| 10848782015587 | K141625 | 000 |
| 10848782015600 | K141625 | 000 |
| 10848782015617 | K141625 | 000 |
| 10848782015679 | K141625 | 000 |
| 10848782015693 | K141625 | 000 |
| 10848782015709 | K141625 | 000 |
| 10848782015747 | K141625 | 000 |
| 10848782015778 | K141625 | 000 |
| 10848782015792 | K141625 | 000 |
| 10848782015808 | K141625 | 000 |
| 10848782015372 | K141625 | 000 |