510(k) K760970

FLORIO CPC BAND by Richard'S Medical Equip., Inc. — Product Code HWN

K760970 is an FDA 510(k) premarket notification submitted by Richard'S Medical Equip., Inc. for the device "FLORIO CPC BAND". The FDA issued a decision of Substantially Equivalent on November 23, 1976. The device falls under product code HWN (Instrument, Compression), a Class I device regulated under 21 CFR 888.4540. Richard'S Medical Equip., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1976
Date Received
November 4, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Compression
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type