510(k) K791859
K791859 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL STIRRUPS STRAP". The FDA issued a decision of Substantially Equivalent on October 4, 1979. The device falls under product code BWN (Table And Attachments, Operating-Room), a Class I device regulated under 21 CFR 878.4950. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 1979
- Date Received
- September 18, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table And Attachments, Operating-Room
- Device Class
- Class I
- Regulation Number
- 878.4950
- Review Panel
- SU
- Submission Type