510(k) K791211
K791211 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "BINDAFIX". The FDA issued a decision of Substantially Equivalent on Aug 3, 1979. The device falls under product code FQM (Bandage, Elastic), a Class I device regulated under 21 CFR 880.5075. Conphar, Inc. has 121 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 1979
- Date Received
- Jul 2, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Bandage, Elastic
- Device Class
- Class I
- Regulation Number
- 880.5075
- Review Panel
- HO
- Submission Type
- 510(k) Exempt