510(k) K871502
- Device
- PERSONNEL PROTECTIVE SHIELD
- Applicant
- CIS-US, INC.
- 510(k) number
- K871502
- Product code
- KPY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-05-08
- Date received
- 1987-04-17
- Regulation
- 892.6500
- Classification name
- Shield, Protective, Personnel
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MALAMUD, PHD
- Address
- 1983 Marcus Ave. Lake Success NY US 11042 11042
FDA Registration Numbers#
- 3008264111
- 3005257704
- 2184007
- 1225691
- 3017496466
- 3040391047
- 2921581
- 3012777736
- 3030194786
- 3034669683
- 3007165189
- 3016846589
- 3005785003
- 1222742
- 3007289408
- 2182762
- 3038632739
- 3014747754
- 3026030534
- 3005908723
- 3017180923
- 3014644369
- 3021970868
- 3012841710
- 3003887292
- 3010147274
- 3011344631
- 3010827261
- 2025851
- 2518443
- 3011253868
- 9613910
- 3005599545
- 3014342658
- 3043648115
- 1048735
- 3007069733
- 3007594755
- 3011529314
- 1932738
- 3016758972
- 3005022483
- 3014663932
- 3017956124
- 9616441
- 1928237
- 3001970230
- 3014314985
- 3012184208
- 3013575574
- 1225473
- 3021023132
- 2024351
- 3016763307
- 3031590635
- 3016989300
- 1218386
- 3005579300
- 3038134332
- 3040389667
- 3026630
- 3015532203
- 1121142
- 9611112
- 3011526299
- 2124215
- 3004776555
- 3023152124
- 1037577
- 3011659880
- 3006621310
- 2087075
- 1825146
- 1644312
- 3009088444
- 3043126854
- 3012690638
- 3016739098
- 8030607
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KPY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110900 | DISPOSABLE THYROID COLLAR | Bloxr Corporation | 2011-06-24 |
| K962622 | INTRA-ORAL THERMOPLASTIC SHIELD | Medtec, Inc. | 1996-10-01 |
| K954456 | THERMOPLASTIC SHIELD | Medtec, Inc. | 1995-12-21 |
| K954146 | UTK-DTE AUTILARY SHIELD | Mallinckrodt Medical | 1995-12-06 |
| K953610 | AUKULYTE | Aukland Medical Plastics, Inc. | 1995-09-26 |
| K951004 | 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) | Kenex , Ltd. | 1995-04-10 |
| K951003 | KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) | Kenex , Ltd. | 1995-04-03 |
| K940539 | STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM | Standard Imaging, Inc. | 1994-03-16 |
| K934206 | MAVIG ANGIO SHIELD MODELS 6290 & 6272 | F. Walter Hanel GmbH | 1993-10-07 |
| K912378 | DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS | Davis Lead Aprons, Inc. | 1992-03-18 |
| K912327 | DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. | Davis Lead Aprons, Inc. | 1992-03-18 |
| K912326 | DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS | Davis Lead Aprons, Inc. | 1992-03-18 |
| K900970 | RADIATION PROTECTION GLASSES | Infab Corp. | 1990-05-01 |
| K896511 | DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL | E.I. Dupont DE Nemours & Co., Inc. | 1989-12-22 |
| K896289 | RADIATION PROTECTION APRON | Infab Corp. | 1989-12-14 |
Legacy Summary#
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FDA Review#
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