The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for The Keymed Fiberscope Sterilization Case.
| Device ID | K860528 |
| 510k Number | K860528 |
| Device Name: | THE KEYMED FIBERSCOPE STERILIZATION CASE |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | KEYMED, INC. KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA Essex Ss2 5qh England, GB |
| Contact | Roger Gray |
| Correspondent | Roger Gray KEYMED, INC. KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA Essex Ss2 5qh England, GB |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-11 |
| Decision Date | 1986-07-15 |