KLINIDRAPE REINFORCED SURGICAL GOWNS


the company

Device Classification Name

gown, surgical

510(k) Number K000902
Device Name KLINIDRAPE REINFORCED SURGICAL GOWNS
Original Applicant
MOLNLYCKE HEALTH CARE, INC.
500 baldwin tower
eddystone, 
PA 
19022

Original Contact miguel a negron
Regulation Number 878.4040
Classification Product Code
FYA  
Date Received 03/21/2000
Decision Date 07/11/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No