The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Haig Nail.
Device ID | K940736 |
510k Number | K940736 |
Device Name: | HAIG NAIL |
Classification | Nail, Fixation, Bone |
Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Contact | Robert E Smith |
Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Product Code | JDS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-17 |
Decision Date | 1994-09-12 |