510(k) K951701
K951701 is an FDA 510(k) premarket notification submitted by Future Medical Systems, Inc. for the device "FMS ARTHRO-CUTTER". The FDA issued a decision of Substantially Equivalent on May 9, 1995. The device falls under product code HNX (Depressor, Orbital), a Class I device regulated under 21 CFR 886.4350. Future Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1995
- Date Received
- April 12, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Depressor, Orbital
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type