510(k) K951300

NEZHAT-DORSEY THERMAL RETENTION SYSTEM by American Hydro-Surgical Instruments, Inc. — Product Code LHC

K951300 is an FDA 510(k) premarket notification submitted by American Hydro-Surgical Instruments, Inc. for the device "NEZHAT-DORSEY THERMAL RETENTION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 20, 1995. The device falls under product code LHC (Warmer, Irrigation Solution), a Class I device regulated under 21 CFR 890.5950. American Hydro-Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1995
Date Received
March 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Irrigation Solution
Device Class
Class I
Regulation Number
890.5950
Review Panel
HO
Submission Type