510(k) K932694
K932694 is an FDA 510(k) premarket notification submitted by Kappler, Inc. for the device "KAPPLER PRO/VENT PROCEDURE GOWN". The FDA issued a decision of Substantially Equivalent on March 29, 1994. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Kappler, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 1994
- Date Received
- June 3, 1993
- 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