SPLASH ASSIST— 510(k) K952303

Substantially Equivalent

Innovative Outsourcing Solutions

FDA 510(k) clearance K952303 for SPLASH ASSIST, Substantially Equivalent on 1995-08-24. Applicant: Innovative Outsourcing Solutions. Device class: 1.

Clearance details

Applicant: Innovative Outsourcing Solutions
Product code: Code LYU
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1995-05-16
Decision date: 1995-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Chelmsford, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYU

K011755 — STRYKER T4 HYTREL (R) TOGAS2001-06-22
K965237 — NURSES BOUFFANT CAP1997-08-27
K970988 — FAR-EAST BOUFFANT CAPS1997-07-10
K964364 — DISPOSABLE APRON1997-02-25
K961791 — DEPUY DISPOSABLE FILTER/HOOD1996-08-09

More clearances from Innovative Outsourcing Solutions

K961402 — STS SHIELD WITH MASK1996-07-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.