Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K882568
Device Name 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY
Applicant
SPEMBLY MEDICAL LTD.
NEWBURY ROAD
ANDOVER HAMPSHIRE SP10 4DR
ENGLAND,  GB
Applicant Contact GORDON COOK
Correspondent
SPEMBLY MEDICAL LTD.
NEWBURY ROAD
ANDOVER HAMPSHIRE SP10 4DR
ENGLAND,  GB
Correspondent Contact GORDON COOK
Regulation Number878.4350
Classification Product Code
GEH  
Date Received06/22/1988
Decision Date 09/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-