The following data is part of a premarket notification filed by Hudson Respiratory Care, Inc. with the FDA for Cath-guide.
Device ID | K955645 |
510k Number | K955645 |
Device Name: | CATH-GUIDE |
Classification | Catheters, Suction, Tracheobronchial |
Applicant | HUDSON RESPIRATORY CARE, INC. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
Contact | Paul E Dryden |
Correspondent | Paul E Dryden HUDSON RESPIRATORY CARE, INC. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
Product Code | BSY |
CFR Regulation Number | 868.6810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-12 |
Decision Date | 1996-03-12 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CATH-GUIDE 75513068 2272128 Live/Registered |
TELEFLEX MEDICAL INCORPORATED 1998-07-06 |
CATH-GUIDE 72411492 0958994 Dead/Cancelled |
HUDSON OXYGEN THERAPY SALES COMPANY 1971-12-30 |