510(k) K860804
K860804 is an FDA 510(k) premarket notification submitted by W.R. Grace & Co.-Conn. for the device "MEDICAL ADHESIVE TAPE". The FDA issued a decision of Substantially Equivalent on Mar 24, 1986. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. W.R. Grace & Co.-Conn. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 24, 1986
- Date Received
- Mar 4, 1986
- 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