FDA.reportPublic FDA data

510(k) K020296

Device
ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
Applicant
Apothecary Products, Inc.
510(k) number
K020296
Product code
EWD
Decision
Substantially Equivalent (SESE)
Decision date
2002-06-25
Date received
2002-01-28
Classification name
Protector, Hearing (Insert)
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
GREG LARSON
Address
11750 12th Ave. S. Burnsville MN US 55337 55337

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
K972923SUPER SILIPLUGS EAR PLUGSInterview Medical Technology Corp.1997-10-27
K971517SILICONE PUTTY EAR PLUGSBentec Medical, Inc.1997-06-02
K962292HEARSAVEREmtech Laboratories1996-10-29
K960500THE VIRTUAL M-332Virtual Corp.1996-04-03
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