510(k) K803306

ALOFT STERILIZATION WRAP by American Hospital Supply Corp. — Product Code FRG

K803306 is an FDA 510(k) premarket notification submitted by American Hospital Supply Corp. for the device "ALOFT STERILIZATION WRAP". The FDA issued a decision of Substantially Equivalent on February 5, 1981. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. American Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1981
Date Received
December 30, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type