510(k) K900195
K900195 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "MODIFIED GORE-TEX SURGICAL TAPE". The FDA issued a decision of Substantially Equivalent on March 13, 1990. The device falls under product code MCA (Tape, Surgical, Internal), a Class II device regulated under 21 CFR 878.3300. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1990
- Date Received
- January 11, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tape, Surgical, Internal
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type