The following data is part of a premarket notification filed by Hougen Mfg., Inc. with the FDA for X-air-ciser.
Device ID | K974849 |
510k Number | K974849 |
Device Name: | X-AIR-CISER |
Classification | Percussor, Powered-electric |
Applicant | HOUGEN MFG., INC. 3001 HOUGEN DR. Swartz Creek, MI 48473 |
Contact | Jeffery R Miller |
Correspondent | Jeffery R Miller HOUGEN MFG., INC. 3001 HOUGEN DR. Swartz Creek, MI 48473 |
Product Code | BYI |
CFR Regulation Number | 868.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-12-29 |
Decision Date | 1998-08-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10383480000065 | K974849 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
X-AIR-CISER 75787112 not registered Dead/Abandoned |
Hougen Manufacturing, Inc. 1999-08-27 |
X-AIR-CISER 75237195 not registered Dead/Abandoned |
Hougen Manufacturing, Inc. 1997-02-06 |