The following data is part of a premarket notification filed by Gobbs Medical, Inc. with the FDA for Hobbs Medical /jayco Multiple Biopsy Instrument.
Device ID | K844551 |
510k Number | K844551 |
Device Name: | HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT |
Classification | Forceps, Biopsy, Non-electric |
Applicant | GOBBS MEDICAL, INC. 497 N. MAIN ST. Palmer, MA 01069 |
Contact | Steven G Richter |
Correspondent | Steven G Richter GOBBS MEDICAL, INC. 497 N. MAIN ST. Palmer, MA 01069 |
Product Code | FCL |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-21 |
Decision Date | 1985-01-03 |