Cleared Traditional

DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)

K972528 · Dyna Corp. · General Hospital

Jul 1997

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K972528 is an FDA 510(k) clearance for the DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759), a Stretcher, Wheeled (Class II — Special Controls, product code FPO), submitted by Dyna Corp. (Carlsbad, US). The FDA issued a Cleared decision on July 28, 1997, 21 days after receiving the submission on July 7, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6910.

Submission Details

510(k) Number	K972528 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 1997
Decision Date	July 28, 1997
Days to Decision	21 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement