FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

PERSONNEL PROTECTIVE SHIELD

K Number: K871502 · Decision May 8, 1987
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
24
Applicant Total
9
Review Days
21

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Basic Information

Device Name
PERSONNEL PROTECTIVE SHIELD
K Number
K871502
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
892.6500
Medical Specialty
Radiology
Decision
Substantially Equivalent
Applicant
Cis-Us, Inc.
Date Received
April 17, 1987
Decision Date
May 8, 1987
Product Code
KPY
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
KPY Shield, Protective, Personnel

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Other Clearances by Cis-Us, Inc.

K Number Device Name
K951708 ELSA-HCT
K950211 ELSA-PTH
K890799 CURIETRON 192 HIGH DOSE RATE
K882449 CESIUM 137 SOURCE, MODEL CSM-40
K865027 IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C
K863778 VENTICIS II
K860823 ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT
K860824 TSHK-NN RIA KIT