510(k) K830153

RICHARDS INTRA-ARTICULAR SHAVER BLADES by Richard'S Medical Equip., Inc. — Product Code GEY

K830153 is an FDA 510(k) premarket notification submitted by Richard'S Medical Equip., Inc. for the device "RICHARDS INTRA-ARTICULAR SHAVER BLADES". The FDA issued a decision of Substantially Equivalent on February 28, 1983. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. Richard'S Medical Equip., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1983
Date Received
January 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Ac-Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type