The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Various Cardiac Cryoprobes Having Dia. & Cos. Diff.
Device ID | K874367 |
510k Number | K874367 |
Device Name: | VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF |
Classification | Unit, Cautery, Thermal, Ac-powered |
Applicant | SPEMBLY MEDICAL LTD. NEWBURY ROAD ANDOVER HAMPSHIRE SP10 4DR England, GB |
Contact | Gordon Cook |
Correspondent | Gordon Cook SPEMBLY MEDICAL LTD. NEWBURY ROAD ANDOVER HAMPSHIRE SP10 4DR England, GB |
Product Code | HQO |
CFR Regulation Number | 886.4115 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-23 |
Decision Date | 1988-01-04 |