510(k) K903823
K903823 is an FDA 510(k) premarket notification submitted by Smith And Nephew Donjoy, Inc. for the device "SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE". The FDA issued a decision of Substantially Equivalent on Jan 16, 1991. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Smith And Nephew Donjoy, Inc. has 14 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 16, 1991
- Date Received
- Aug 20, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Tape And Bandage, Adhesive
- Device Class
- Class I
- Regulation Number
- 880.5240
- Review Panel
- SU
- Submission Type
- 510(k) Exempt