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510(k) K960500

Device
THE VIRTUAL M-332
Applicant
VIRTUAL CORP.
510(k) number
K960500
Product code
EWD  
Decision
Substantially Equivalent (SESE)
Decision date
1996-04-03
Date received
1996-02-02
Regulation
510(k) Premarket Notification
Classification name
Protector, Hearing (insert)
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
Ear Nose & Throat
Device class
U
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JONATHAN D BIRCK
Address
521 SW 11th Suite 400 Portland OR US 97205 97205

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EWD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K020296ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057Apothecary Products, Inc.2002-06-25
K972923SUPER SILIPLUGS EAR PLUGSInterview Medical Technology Corp.1997-10-27
K971517SILICONE PUTTY EAR PLUGSBentec Medical, Inc.1997-06-02
K962292HEARSAVEREmtech Laboratories1996-10-29
K945376DOC'S PROPLUGS EAR PLUGSDoc'S Proplugs, Inc.1995-11-14
K930203MODEL 322 CLINICAL AUDIOMETERVirtual Corp.1993-07-08
K915739#903 SILAFLEX IIFlents Products Co., Inc.1992-06-30
K910177SEAL-RITE SILICONE EAR PLUGFlents Products Co., Inc.1991-06-24
K862045DOC'S PROPLUGS EAR PLUGSDoc'S Proplugs, Inc.1987-04-10
K821187MEDCO CUSTOM EAR PROTECTOR MOLD KITSanta Barbara Medco, Inc.1982-05-27
K791608BILSOM PROPPBilson International, Inc.1979-10-10
K781907EAR STOPPLES FOR NOISE ATTENTIONCrown Delta Corp.1978-11-22
K781491PRO-MOLD, CUSTOM EARMcghan Medical Corp.1978-09-27

Legacy Summary#

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FDA Review#

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