510(k) K791960
K791960 is an FDA 510(k) premarket notification submitted by 3M Company for the device "ROTH-KENNEDY PASSER". The FDA issued a decision of Substantially Equivalent on October 4, 1979. The device falls under product code HWQ (Passer), a Class I device regulated under 21 CFR 888.4540. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 1979
- Date Received
- October 1, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Passer
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type