510(k) K801036
K801036 is an FDA 510(k) premarket notification submitted by American Threshold Industries, Inc. for the device "SURGICAL MASK". The FDA issued a decision of Substantially Equivalent on June 4, 1980. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. American Threshold Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 1980
- Date Received
- May 2, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type