510(k) K801850

CHARLES PNEUMATIC INTRAOCULAR SCISSORS by Cooper Medical Devices Corp. — Product Code HQE

K801850 is an FDA 510(k) premarket notification submitted by Cooper Medical Devices Corp. for the device "CHARLES PNEUMATIC INTRAOCULAR SCISSORS". The FDA issued a decision of Substantially Equivalent on September 16, 1980. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Cooper Medical Devices Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
August 4, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type