HOFFMAN IVF-1

Accessory, Assisted Reproduction

(ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION

The following data is part of a premarket notification filed by (arms) Hoffman Surgical Equipment, Ivf Division with the FDA for Hoffman Ivf-1.

Pre-market Notification Details

Device IDK991216
510k NumberK991216
Device Name:HOFFMAN IVF-1
ClassificationAccessory, Assisted Reproduction
Applicant (ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION 555 NORTH LN. SUITE 5001 Conshohocken,  PA  19428
ContactFrank Strzempek
CorrespondentFrank Strzempek
(ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION 555 NORTH LN. SUITE 5001 Conshohocken,  PA  19428
Product CodeMQG  
CFR Regulation Number884.6120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-09
Decision Date1999-08-05

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