The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Sharpoint Coated, Fast Absorbing Polyglycolic Acid Synthetic Suture, Undyed.
| Device ID | K014021 |
| 510k Number | K014021 |
| Device Name: | SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Contact | Elizabeth Lazaro |
| Correspondent | Elizabeth Lazaro SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-06 |
| Decision Date | 2002-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889950000318 | K014021 | 000 |
| 10848782017659 | K014021 | 000 |
| 10848782017642 | K014021 | 000 |
| 10848782017635 | K014021 | 000 |
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| 10848782017611 | K014021 | 000 |
| 10848782017604 | K014021 | 000 |
| 10848782017581 | K014021 | 000 |
| 10848782017567 | K014021 | 000 |
| 10848782017550 | K014021 | 000 |
| 10848782017543 | K014021 | 000 |
| 10848782017536 | K014021 | 000 |
| 10848782017529 | K014021 | 000 |
| 10848782017512 | K014021 | 000 |
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| 10848782017499 | K014021 | 000 |
| 10848782017482 | K014021 | 000 |
| 10304040039714 | K014021 | 000 |
| 10848782017666 | K014021 | 000 |
| 10848782017673 | K014021 | 000 |
| 10848782017697 | K014021 | 000 |
| 10889950000288 | K014021 | 000 |
| 10889813000257 | K014021 | 000 |
| 10848782029218 | K014021 | 000 |
| 10848782029201 | K014021 | 000 |
| 10848782023100 | K014021 | 000 |
| 10848782023094 | K014021 | 000 |
| 10848782023087 | K014021 | 000 |
| 10848782023070 | K014021 | 000 |
| 10848782023063 | K014021 | 000 |
| 10848782017772 | K014021 | 000 |
| 10848782017765 | K014021 | 000 |
| 10848782017758 | K014021 | 000 |
| 10848782017741 | K014021 | 000 |
| 10848782017734 | K014021 | 000 |
| 10848782017727 | K014021 | 000 |
| 10848782017710 | K014021 | 000 |
| 10848782017703 | K014021 | 000 |
| 10304040039684 | K014021 | 000 |