510(k) K811958
K811958 is an FDA 510(k) premarket notification submitted by The Buckeye Cellulose Corp. for the device "BOUNDARY REINFORCED OR GOWN". The FDA issued a decision of Substantially Equivalent on July 27, 1981. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. The Buckeye Cellulose Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1981
- Date Received
- July 9, 1981
- 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