The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Convertors Sms Polyolefin Gown.
Device ID | K020593 |
510k Number | K020593 |
Device Name: | CONVERTORS SMS POLYOLEFIN GOWN |
Classification | Gown, Surgical |
Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park, IL 60085 |
Contact | Sharon Robbins |
Correspondent | Sharon Robbins ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park, IL 60085 |
Product Code | FYA |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-22 |
Decision Date | 2002-03-18 |
Summary: | summary |