510(k) K883376

STERILIZATION WRAP TYPE 22,44,77 by East Texas Lighthouse For the Blind — Product Code FRG

K883376 is an FDA 510(k) premarket notification submitted by East Texas Lighthouse For the Blind for the device "STERILIZATION WRAP TYPE 22,44,77". The FDA issued a decision of Substantially Equivalent on September 28, 1988. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. East Texas Lighthouse For the Blind has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1988
Date Received
August 9, 1988
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