510(k) K934664
K934664 is an FDA 510(k) premarket notification submitted by Mallinckrodt Group, Inc. for the device "HYDRAGOWN". The FDA issued a decision of Substantially Equivalent on May 24, 1994. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Mallinckrodt Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 1994
- Date Received
- September 28, 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