The following data is part of a premarket notification filed by Thomasville Medical Assoc. with the FDA for Calmps: Bone, Mastin, Lewin, Brand.
| Device ID | K930028 |
| 510k Number | K930028 |
| Device Name: | CALMPS: BONE, MASTIN, LEWIN, BRAND |
| Classification | Orthopedic Manual Surgical Instrument |
| Applicant | THOMASVILLE MEDICAL ASSOC. 1100-B CAMBRIDGE SQUARE Alpharetta, GA 30201 |
| Contact | Thomas J Zinnanti |
| Correspondent | Thomas J Zinnanti THOMASVILLE MEDICAL ASSOC. 1100-B CAMBRIDGE SQUARE Alpharetta, GA 30201 |
| Product Code | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-05 |
| Decision Date | 1993-02-16 |