DIVE AND SHALLOW AND GRAND DIVE


Device Classification Name

chamber, hyperbaric

510(k) Number K072757
Device Name DIVE AND SHALLOW AND GRAND DIVE
Applicant
SUMMIT TO SEA
1744 avocet lane
mound, 
MN 
55364

Applicant Contact bruce mckeeman
Correspondent
SUMMIT TO SEA
1744 avocet lane
mound, 
MN 
55364

Correspodent Contact bruce mckeeman
Regulation Number 868.5470
Classification Product Code
CBF  
Date Received 09/27/2007
Decision Date 02/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No