510(k) K922355

POLLY'S VITREOUS SCISSORS J-225-S by O.R. Specialties, Inc. — Product Code HQE

K922355 is an FDA 510(k) premarket notification submitted by O.R. Specialties, Inc. for the device "POLLY'S VITREOUS SCISSORS J-225-S". The FDA issued a decision of Substantially Equivalent on August 18, 1992. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. O.R. Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1992
Date Received
May 19, 1992
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