The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Clearview Blower/mister.
Device ID | K973485 |
510k Number | K973485 |
Device Name: | CLEARVIEW BLOWER/MISTER |
Classification | Lavage, Jet |
Applicant | DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
Contact | Gretchen Hartlage |
Correspondent | Gretchen Hartlage DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
Product Code | FQH |
CFR Regulation Number | 880.5475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-15 |
Decision Date | 1997-12-08 |
Summary: | summary |