The following data is part of a premarket notification filed by North American Sterilization & Packaging Co. with the FDA for Olympus Uretero. & Circon Acmi Uretero. Guide.
| Device ID | K896821 |
| 510k Number | K896821 |
| Device Name: | OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE |
| Classification | Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) |
| Applicant | NORTH AMERICAN STERILIZATION & PACKAGING CO. 15 WHITE LAKE RD. P.O. BOX 923 Sparta, NJ 07871 |
| Contact | A Schlakman |
| Correspondent | A Schlakman NORTH AMERICAN STERILIZATION & PACKAGING CO. 15 WHITE LAKE RD. P.O. BOX 923 Sparta, NJ 07871 |
| Product Code | KOQ |
| CFR Regulation Number | 872.3410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-04 |
| Decision Date | 1990-02-09 |