510(k) K926519
K926519 is an FDA 510(k) premarket notification submitted by Custom Medical Products, Ltd. for the device "SURGICAL GOWN". The FDA issued a decision of Substantially Equivalent on August 12, 1993. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Custom Medical Products, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1993
- Date Received
- December 30, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type