510(k) K873175

CENTRAL SUPPLY ROOM WRAP by Ulti-Med Intl., Inc. — Product Code FRG

K873175 is an FDA 510(k) premarket notification submitted by Ulti-Med Intl., Inc. for the device "CENTRAL SUPPLY ROOM WRAP". The FDA issued a decision of Substantially Equivalent on September 9, 1987. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Ulti-Med Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1987
Date Received
August 12, 1987
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