510(k) K952303
K952303 is an FDA 510(k) premarket notification submitted by Innovative Outsourcing Solutions for the device "SPLASH ASSIST". The FDA issued a decision of Substantially Equivalent on August 24, 1995. The device falls under product code LYU (Accessory, Surgical Apparel), a Class I 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
- August 24, 1995
- Date Received
- May 16, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory, Surgical Apparel
- Device Class
- Class I
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type