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510(k) K963461

Device
SAFETY PONCHO/SHOULDER STRAP PONCHO
Applicant
SKIL-CARE CORP.
510(k) number
K963461
Product code
KID  
Decision
Substantially Equivalent (SESE)
Decision date
1996-10-11
Date received
1996-09-03
Regulation
890.3910
Classification name
Restraint, Wheelchair, Non-protective
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ARNOLD SILVERMAN
Address
167 Saw Mill River Rd. Yonkers NY US 10701 10701

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KID  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K963479WHEELCHAIR BELTDeroyal Industries, Inc.1997-01-24
K963475PONCHO VEST RESTRAINTDeroyal Industries, Inc.1997-01-22
K963480MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDERDeroyal Industries, Inc.1997-01-22
K963459SUPPORT VESTSkil-Care Corp.1996-10-15
K963455SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROLSkil-Care Corp.1996-10-08
K802603ECONO-FLOAT WHEELCHAIR FLOTATION CUSHIONJefferson Industries, Inc.1980-11-12

Legacy Summary#

summary

FDA Review#

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