The following data is part of a premarket notification filed by Poly-medics,inc. with the FDA for Lactosorb Pop Rivet.
| Device ID | K951658 |
| 510k Number | K951658 |
| Device Name: | LACTOSORB POP RIVET |
| Classification | Staple, Fixation, Bone |
| Applicant | POLY-MEDICS,INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary L Verstynen |
| Correspondent | Mary L Verstynen POLY-MEDICS,INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-10 |
| Decision Date | 1995-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304421264 | K951658 | 000 |
| 00880304421240 | K951658 | 000 |