The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Hobbs Medical/jayco Aspiration Catheter.
Device ID | K844550 |
510k Number | K844550 |
Device Name: | HOBBS MEDICAL/JAYCO ASPIRATION CATHETER |
Classification | Endoscopic Irrigation/suction System |
Applicant | HOBBS MEDICAL, INC. 497 N. MAIN ST. Palmer, MA 01069 |
Contact | Steven G Richter |
Correspondent | Steven G Richter HOBBS MEDICAL, INC. 497 N. MAIN ST. Palmer, MA 01069 |
Product Code | OCX |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-21 |
Decision Date | 1985-01-03 |