The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Sharpoint Pdo (polydioxanone) Sutures.
| Device ID | K063680 |
| 510k Number | K063680 |
| Device Name: | SHARPOINT PDO (POLYDIOXANONE) SUTURES |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| 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 | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-11 |
| Decision Date | 2007-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782017864 | K063680 | 000 |
| 10848782030771 | K063680 | 000 |
| 10848782031051 | K063680 | 000 |
| 10848782031068 | K063680 | 000 |
| 10848782031075 | K063680 | 000 |
| 10848782031082 | K063680 | 000 |
| 10848782031099 | K063680 | 000 |
| 10848782031105 | K063680 | 000 |
| 10848782031112 | K063680 | 000 |
| 10848782018250 | K063680 | 000 |
| 10848782018243 | K063680 | 000 |
| 10848782018175 | K063680 | 000 |
| 10848782017956 | K063680 | 000 |
| 10848782017963 | K063680 | 000 |
| 10848782017994 | K063680 | 000 |
| 10848782018021 | K063680 | 000 |
| 10848782018076 | K063680 | 000 |
| 10848782018106 | K063680 | 000 |
| 10848782018151 | K063680 | 000 |
| 10848782018168 | K063680 | 000 |
| 10848782031129 | K063680 | 000 |
| 10848782031136 | K063680 | 000 |
| 10848782031143 | K063680 | 000 |
| 10848782031792 | K063680 | 000 |
| 10848782031808 | K063680 | 000 |
| 10848782033031 | K063680 | 000 |
| 00848782033041 | K063680 | 000 |
| 10848782033055 | K063680 | 000 |
| 10848782033062 | K063680 | 000 |
| 10848782033079 | K063680 | 000 |
| 10848782033086 | K063680 | 000 |
| 10848782031785 | K063680 | 000 |
| 10848782031778 | K063680 | 000 |
| 10848782031761 | K063680 | 000 |
| 10848782031150 | K063680 | 000 |
| 10848782031167 | K063680 | 000 |
| 10848782031174 | K063680 | 000 |
| 10848782031181 | K063680 | 000 |
| 00848782031191 | K063680 | 000 |
| 10848782031204 | K063680 | 000 |
| 10848782031211 | K063680 | 000 |
| 10848782031754 | K063680 | 000 |
| 10848782033093 | K063680 | 000 |