510(k) K760970
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