510(k) K894760
K894760 is an FDA 510(k) premarket notification submitted by Barrier Concepts, Inc. for the device "CLOTHINGUARD". The FDA issued a decision of Substantially Equivalent on August 18, 1989. The device falls under product code FYE (Dress, Surgical), a Class I device regulated under 21 CFR 878.4040. Barrier Concepts, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1989
- Date Received
- July 27, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dress, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4040
- Review Panel
- SU
- Submission Type