The following data is part of a premarket notification filed by Collagen Corp. with the FDA for Dental Hand Instruments.
| Device ID | K883322 |
| 510k Number | K883322 |
| Device Name: | DENTAL HAND INSTRUMENTS |
| Classification | Burnisher, Operative |
| Applicant | COLLAGEN CORP. 2500 FABER PL. Palo Alto, CA 94303 |
| Contact | Robin Bush |
| Correspondent | Robin Bush COLLAGEN CORP. 2500 FABER PL. Palo Alto, CA 94303 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-05 |
| Decision Date | 1988-08-26 |