TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX


Device Classification Name

blood pressure cuff

510(k) Number K080189
Device Name TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX
Applicant
TRIMLINE MEDICAL PRODUCTS CORP.
34 columbia ave.
branchburg, 
NJ 
08876

Applicant Contact nancy skocypec
Correspondent
TRIMLINE MEDICAL PRODUCTS CORP.
34 columbia ave.
branchburg, 
NJ 
08876

Correspodent Contact nancy skocypec
Regulation Number 870.1120
Classification Product Code
DXQ  
Date Received 01/25/2008
Decision Date 08/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No