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 |