HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089


Device Classification Name

sleeve, limb, compressible

510(k) Number K021509
Device Name HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089
Original Applicant
HYGIA HEALTH SERVICES, INC.
2800 milan ct., suite 259
birmingham, 
AL 
35211

Original Contact geoff m fatzinger
Regulation Number 870.5800
Classification Product Code
JOW  
Date Received 05/09/2002
Decision Date 12/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No