510(k) K792065
K792065 is an FDA 510(k) premarket notification submitted by Norman R. Sanborn Co. for the device "POROUS ELASTIC RUBBER BANDAGE". The FDA issued a decision of Substantially Equivalent on Nov 20, 1979. The device falls under product code FQM (Bandage, Elastic), a Class I device regulated under 21 CFR 880.5075.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 20, 1979
- Date Received
- Oct 15, 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