510(k) K931875

AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE by Amsco Sterile Recoveries, Inc. — Product Code FRG

K931875 is an FDA 510(k) premarket notification submitted by Amsco Sterile Recoveries, Inc. for the device "AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE". The FDA issued a decision of Substantially Equivalent on June 10, 1994. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Amsco Sterile Recoveries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1994
Date Received
April 14, 1993
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