510(k) K896724

CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU. by Stiefel Research Institute, Inc. — Product Code GEH

K896724 is an FDA 510(k) premarket notification submitted by Stiefel Research Institute, Inc. for the device "CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU.". The FDA issued a decision of Substantially Equivalent on January 9, 1990. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Stiefel Research Institute, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1990
Date Received
November 29, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type