Device Classification Name |
Lavage, Jet
|
510(k) Number |
K973485 |
Device Name |
CLEARVIEW BLOWER/MISTER |
Applicant |
DLP, INC. |
620 WATSON S.W., P.O. BOX 409 |
GRAND RAPIDS,
MI
49501
|
|
Applicant Contact |
GRETCHEN HARTLAGE |
Correspondent |
DLP, INC. |
620 WATSON S.W., P.O. BOX 409 |
GRAND RAPIDS,
MI
49501
|
|
Correspondent Contact |
GRETCHEN HARTLAGE |
Regulation Number | 880.5475
|
Classification Product Code |
|
Date Received | 09/15/1997 |
Decision Date | 12/08/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|