The following data is part of a premarket notification filed by Implicitcare, Llc with the FDA for Implicitguide Surgical Suture System.
| Device ID | K091061 |
| 510k Number | K091061 |
| Device Name: | IMPLICITGUIDE SURGICAL SUTURE SYSTEM |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | IMPLICITCARE, LLC 13221 MARICOTTE PLACE San Diego, CA 92130 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler IMPLICITCARE, LLC 13221 MARICOTTE PLACE San Diego, CA 92130 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-14 |
| Decision Date | 2009-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861810000310 | K091061 | 000 |
| 00861810000303 | K091061 | 000 |