The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for The Keymed Sigmoidoscope Disinfection Stand.
Device ID | K860704 |
510k Number | K860704 |
Device Name: | THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND |
Classification | Accessories, Germicide, Cleaning, For Endoscopes |
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 | NZA |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-26 |
Decision Date | 1986-06-17 |