The following data is part of a premarket notification filed by Poly-medics,inc. with the FDA for Lactosorb Suture Anchor.
| Device ID | K954443 |
| 510k Number | K954443 |
| Device Name: | LACTOSORB SUTURE ANCHOR |
| Classification | Staple, Fixation, Bone |
| Applicant | POLY-MEDICS,INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary Verstynen |
| Correspondent | Mary 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 | 1995-09-25 |
| Decision Date | 1996-01-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304007048 | K954443 | 000 |