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510(k) K821638

Device
HYGIENE ADAPTORS
Applicant
FRED SAMMONS, INC.
510(k) number
K821638
Product code
ILS  
Decision
Substantially Equivalent (SESE)
Decision date
1982-06-11
Date received
1982-06-03
Regulation
890.5050
Classification name
Adaptor, Hygiene
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ILS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K852049MEDICAL TOILET SEATPedro Aleman1985-06-24
K842651COMMODE CHAIR 98200Guardian Products Co., Inc.1984-08-07
K830853LAVATORY SEAT HEIGHTENERLic-Orthion1983-06-08
K831547RAISED TOILET SEATS & NAIL CLIPPERSFred Sammons, Inc.1983-06-08
K830425TOILET SEAT RAISEDMaddak, Inc.1983-05-09
K830852SHOWER STOOL W/HANDLESLic-Orthion1983-04-05
K823641BATHING CHAIR FOR CHILDFred Sammons, Inc.1983-01-21
K823626DISPOSABLE TOOTH BRUSHFred Sammons, Inc.1982-12-30
K823606PLASTIC BREAK RESISTANT MIRRORFred Sammons, Inc.1982-12-28
K823155LAVATORY SEAT HEIGHTENEROrthion Corp.1982-11-05
K823156COLLAPSABLE LAVATORY HEIGHTENEROrthion Corp.1982-11-05
K821860BK-6477 THE DERBY RAISED TOILET SEATFred Sammons, Inc.1982-07-02
K821009BATHTUB GRAB BARGuardian Products Co., Inc.1982-04-21
K813635CHILDS TOILET TRAINER HYGIENE AIDSFred Sammons, Inc.1982-01-19
K812352HYGIENE ADAPTORSFred Sammons, Inc.1981-09-14

Legacy Summary#

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FDA Review#

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