510(k) K894802
K894802 is an FDA 510(k) premarket notification submitted by American White Cross, Inc. for the device "AWC BUTTERFLY WOUND CLOSURES". The FDA issued a decision of Substantially Equivalent on January 31, 1990. The device falls under product code FPX (Strip, Adhesive, Closure, Skin), a Class I device regulated under 21 CFR 880.5240. American White Cross, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1990
- Date Received
- July 28, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strip, Adhesive, Closure, Skin
- Device Class
- Class I
- Regulation Number
- 880.5240
- Review Panel
- SU
- Submission Type