The following data is part of a premarket notification filed by Poly-medics,inc. with the FDA for Lactosorb Trauma Plating System.
| Device ID | K960988 |
| 510k Number | K960988 |
| Device Name: | LACTOSORB TRAUMA PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | POLY-MEDICS,INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | William S Pietrzak, Ph.d. |
| Correspondent | William S Pietrzak, Ph.d. POLY-MEDICS,INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-07 |
| Decision Date | 1996-04-10 |
| Summary: | summary |