The following data is part of a premarket notification filed by International Hospital Supply Co. with the FDA for Bone Nail, Kuntscher.
| Device ID | K911982 |
| 510k Number | K911982 |
| Device Name: | BONE NAIL, KUNTSCHER |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | INTERNATIONAL HOSPITAL SUPPLY CO. 18321 VENTURA BLVD. #1010 Tarzana, CA 91356 |
| Contact | George O Shecter |
| Correspondent | George O Shecter INTERNATIONAL HOSPITAL SUPPLY CO. 18321 VENTURA BLVD. #1010 Tarzana, CA 91356 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-03 |
| Decision Date | 1991-07-26 |