510(k) K902763

STERILE INSTRUMENT DRAPE by North American Sterilization & Packaging Co. — Product Code HMW

K902763 is an FDA 510(k) premarket notification submitted by North American Sterilization & Packaging Co. for the device "STERILE INSTRUMENT DRAPE". The FDA issued a decision of Substantially Equivalent on September 20, 1990. The device falls under product code HMW (Drape, Microscope, Ophthalmic), a Class II device regulated under 21 CFR 878.4370. North American Sterilization & Packaging Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1990
Date Received
June 25, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Microscope, Ophthalmic
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type