FDA.report

510(k) K991216

Device
HOFFMAN IVF-1
Applicant
(ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION
510(k) number
K991216
Product code
MQG  
Decision
Substantially Equivalent (SESE)
Decision date
1999-08-05
Date received
1999-04-09
Regulation
884.6120
Classification name
Accessory, Assisted Reproduction
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
FRANK STRZEMPEK
Address
555 N. Ln. Suite 5001 Conshohocken PA US 19428 19428

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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