The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica Mono-tube Single Pin Clamp.
| Device ID | K934698 |
| 510k Number | K934698 |
| Device Name: | HOWMEDICA MONO-TUBE SINGLE PIN CLAMP |
| Classification | Component, Traction, Invasive |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Mary C Spicer |
| Correspondent | Mary C Spicer HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-30 |
| Decision Date | 1994-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327092301 | K934698 | 000 |
| 07613327092295 | K934698 | 000 |
| 07613327092288 | K934698 | 000 |