The following data is part of a premarket notification filed by Precision-cosmet Co., Inc. with the FDA for Precision - Cosmet Capsule Coupeur.
| Device ID | K852934 |
| 510k Number | K852934 |
| Device Name: | PRECISION - COSMET CAPSULE COUPEUR |
| Classification | Cystotome |
| Applicant | PRECISION-COSMET CO., INC. 11140 BREN RD. W. Minnetonka, MN 55343 |
| Contact | Robert L Ullen |
| Correspondent | Robert L Ullen PRECISION-COSMET CO., INC. 11140 BREN RD. W. Minnetonka, MN 55343 |
| Product Code | HNY |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-09 |
| Decision Date | 1985-08-08 |