The following data is part of a premarket notification filed by Jay H. Geller with the FDA for Hawley Retainer Orthodontic Applicance Kit.
| Device ID | K943334 |
| 510k Number | K943334 |
| Device Name: | HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT |
| Classification | Wire, Orthodontic |
| Applicant | JAY H. GELLER EAST TOWER, SUITE 600 2425 WEST OLYMPIC BLVD. Santa Monica, CA 90404 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller JAY H. GELLER EAST TOWER, SUITE 600 2425 WEST OLYMPIC BLVD. Santa Monica, CA 90404 |
| Product Code | DZC |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-12 |
| Decision Date | 1994-10-05 |