510(k) K925215

STERILE SURGICAL INSTRUMENT TRAYS by American Healthcare Supply Co., Inc. — Product Code KDD

K925215 is an FDA 510(k) premarket notification submitted by American Healthcare Supply Co., Inc. for the device "STERILE SURGICAL INSTRUMENT TRAYS". The FDA issued a decision of Substantially Equivalent (kit, denovo) on June 1, 1993. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. American Healthcare Supply Co., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
June 1, 1993
Date Received
October 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Surgical Instrument, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type