510(k) K800730
K800730 is an FDA 510(k) premarket notification submitted by Stainless Mfg., Inc. for the device "RETROGRADE KNIFE". The FDA issued a decision of Substantially Equivalent on April 8, 1980. The device falls under product code HXP (Instrument, Bending Or Contouring), a Class I device regulated under 21 CFR 888.4540. Stainless Mfg., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1980
- Date Received
- April 1, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Bending Or Contouring
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type