The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for 130 Cryo Unit & Assoc. Cryoprobes & Spray.
Device ID | K882568 |
510k Number | K882568 |
Device Name: | 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY |
Classification | Unit, Cryosurgical, Accessories |
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 | GEH |
CFR Regulation Number | 878.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-22 |
Decision Date | 1988-09-27 |