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510(k) K912071

Device
SPACE(TM) 7500
Applicant
F.M. WIEST USA, INC.
510(k) number
K912071
Product code
LST  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-09
Date received
1991-05-10
Regulation
510(k) Premarket Notification
Classification name
Device, Erectile Dysfunction
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GEORGE R BATCHELOR
Address
690 Kinderkamack Rd., 1st Floor P.O. Box 637 Oradell NJ US 07649 07649

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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