Device Classification Name |
gown, surgical
|
510(k) Number |
K040485 |
Device Name |
MAXAIR SURGICAL HELMET SYSTEM |
Applicant |
BIO-MEDICAL DEVICES, INC. |
17171 DAIMLER AVE. |
IRVINE,
CA
92614
|
|
Applicant Contact |
NICK HERBERT |
Correspondent |
BIO-MEDICAL DEVICES, INC. |
17171 DAIMLER AVE. |
IRVINE,
CA
92614
|
|
Correspondent Contact |
NICK HERBERT |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 02/25/2004 |
Decision Date | 10/18/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|