510(k) K961402
K961402 is an FDA 510(k) premarket notification submitted by Innovative Outsourcing Solutions for the device "STS SHIELD WITH MASK". The FDA issued a decision of Substantially Equivalent on July 12, 1996. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Innovative Outsourcing Solutions has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 1996
- Date Received
- April 11, 1996
- 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