TBI NEEDLE

Needle, Aspiration And Injection, Disposable

HOBBS MEDICAL, INC.

The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Tbi Needle.

Pre-market Notification Details

Device IDK860582
510k NumberK860582
Device Name:TBI NEEDLE
ClassificationNeedle, Aspiration And Injection, Disposable
Applicant HOBBS MEDICAL, INC. P.O. BOX 46 SPRING STREET Stafford Springs,  CT  06076
ContactSteven G Richter
CorrespondentSteven G Richter
HOBBS MEDICAL, INC. P.O. BOX 46 SPRING STREET Stafford Springs,  CT  06076
Product CodeGAA  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-18
Decision Date1986-03-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M84946210 K860582 000

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