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 | Device Class | Medical Specialty |
|---|---|---|---|
| KPY | Shield, Protective, Personnel | FDA class 1 | Radiology |
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Other Clearances by Cis-Us, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951708 | ELSA-HCT | Sep 5, 1995 | Substantially Equivalent |
| K950211 | ELSA-PTH | Apr 13, 1995 | Substantially Equivalent |
| K890799 | CURIETRON 192 HIGH DOSE RATE | Oct 27, 1989 | Substantially Equivalent |
| K882449 | CESIUM 137 SOURCE, MODEL CSM-40 | Apr 14, 1989 | Substantially Equivalent |
| K865027 | IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C | Feb 26, 1987 | Substantially Equivalent |
| K863778 | VENTICIS II | Oct 27, 1986 | Substantially Equivalent |
| K860823 | ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT | Aug 19, 1986 | Substantially Equivalent |
| K860824 | TSHK-NN RIA KIT | Apr 28, 1986 | Substantially Equivalent |