The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Hobbs Medical Cleaning Brush.
Device ID | K933354 |
510k Number | K933354 |
Device Name: | HOBBS MEDICAL CLEANING BRUSH |
Classification | Accessories, Cleaning, For Endoscope |
Applicant | HOBBS MEDICAL, INC. 497 N. MAIN ST. Palmer, MA 01069 |
Contact | Rob Whalen |
Correspondent | Rob Whalen HOBBS MEDICAL, INC. 497 N. MAIN ST. Palmer, MA 01069 |
Product Code | FEB |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-09 |
Decision Date | 1993-10-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M84946773 | K933354 | 000 |
M84946763 | K933354 | 000 |
M84946653 | K933354 | 000 |
M84946603 | K933354 | 000 |