510(k) K900195
- Device
- Modified Gore-tex Surgical Tape
- Applicant
- W.L. GORE & ASSOCIATES,INC
- 510(k) number
- K900195
- Product code
- MCA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-03-13
- Date received
- 1990-01-11
- Regulation
- 878.3300
- Classification name
- Tape, Surgical, Internal
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CRAIG NEWMAN
- Address
- 3450 W. Kiltie Ln. P.O. Box 500 Flagstaff AZ US 86002 86002
FDA Registration Numbers#
- 9612501
- 1219930
- 3018094310
Source Documents#
510(k) summary PDF not indicated by FDA