510(k) K873723
K873723 is an FDA 510(k) premarket notification submitted by Martin Medical for the device "PLASTER VACUUM, 230V MODEL NO. 4183-161". The FDA issued a decision of Substantially Equivalent on December 10, 1987. The device falls under product code LGH (Instrument, Cast Removal, Ac-Powered), a Class I device regulated under 21 CFR 888.5960. Martin Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1987
- Date Received
- September 15, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Cast Removal, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 888.5960
- Review Panel
- OR
- Submission Type