510(k) K820363
K820363 is an FDA 510(k) premarket notification submitted by Alphamedix, Inc. for the device "DISPOSABLE SURGICAL GARMENTS". The FDA issued a decision of Substantially Equivalent on March 8, 1982. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Alphamedix, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 1982
- Date Received
- February 9, 1982
- 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