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510(k) K821010

Device
BATHTUB TRANSFER BENCH
Applicant
GUARDIAN PRODUCTS CO., INC.
510(k) number
K821010
Product code
IKX  
Decision
Substantially Equivalent (SESE)
Decision date
1982-04-21
Date received
1982-04-12
Regulation
890.5050
Classification name
Aid, Transfer
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 IKX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862895TRICYCLESMednet, Inc.1986-08-13
K842650WALL GRAB BARS 98130-98136Guardian Products Co., Inc.1984-08-10
K831541TUB TRANSFER BENCH BK6481Fred Sammons, Inc.1983-06-02
K823639BOARD TO TRANSFER PARALYZED PATIENT FROMFred Sammons, Inc.1983-01-21
K823640BATH TUB SAFETY BARFred Sammons, Inc.1983-01-21
K823634CHAIR OR BED LEG EXTENDERSFred Sammons, Inc.1982-12-28
K823153BATH TUB SEAT & BATH BOARDOrthion Corp.1982-11-05
K823154SHOWER STOOL W/HANDLESOrthion Corp.1982-11-05
K821903DISC-O-AIDM. Dahm International Aps1982-07-20
K813629BK-6111 HI-D TRANSFER BOARDFred Sammons, Inc.1982-01-19
K812475TRANSFER BENCHMaddak, Inc.1981-09-14
K810449TRANSFER AIDSFred Sammons, Inc.1981-03-04
K810275GRAB BARSMaddak, Inc.1981-02-12
K792247TAYLOR PATIENT TRANSFER BOARDTaylor Medical Equipment1979-11-30
K781201BOARD, TRANSFER, FENDERFred Sammons, Inc.1978-07-31

Legacy Summary#

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FDA Review#

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