510(k) K953610
- Device
- AUKULYTE
- Applicant
- AUKLAND MEDICAL PLASTICS, INC.
- 510(k) number
- K953610
- Product code
- KPY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-09-26
- Date received
- 1995-08-02
- Regulation
- 892.6500
- Classification name
- Shield, Protective, Personnel
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- NORMAN A GRAY
- Address
- P.O. Box 5624 Cary NC US 27512 27512
FDA Registration Numbers#
- 2939388
- 8022247
- 9611112
- 3010041511
- 3009540572
- 2025851
- 2024351
- 3014819517
- 3011593607
- 3008931233
- 3031590635
- 3011659880
- 1644312
- 3005908723
- 3038282968
- 3033484057
- 3016739098
- 3009222501
- 2182762
- 1928237
- 3026326493
- 3014314985
- 1225473
- 3008062466
- 3014273526
- 3011526299
- 3011253868
- 3026030534
- 2184007
- 3016759113
- 3002707546
- 2529126
- 3016948452
- 3011310668
- 3010827261
- 3017496466
- 3020824984
- 3013646819
- 3005022483
- 3038134332
- 3010198795
- 3003768277
- 3038632739
- 3002821232
- 3015495690
- 3038966231
- 3031755043
- 8030607
- 1314417
- 1219183
- 3003967959
- 3017636959
- 3013374101
- 3010147274
- 3004776555
- 3017397209
- 3002806603
- 3013575574
- 3008044484
- 3013070673
- 3026630
- 2518443
- 3016147813
- 1061124
- 1057495
- 3009688745
- 3013285519
- 3013260641
- 3031184338
- 3016846589
- 2431224
- 2247992
- 3003965134
- 3034565743
- 3016758972
- 1048735
- 1222742
- 3016257387
- 3025001668
- 3003887292
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 |
| 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 |
| K912326 | DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS | Davis Lead Aprons, Inc. | 1992-03-18 |
| K912327 | DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. | Davis Lead Aprons, Inc. | 1992-03-18 |
| K912378 | DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. 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 |
| K871502 | PERSONNEL PROTECTIVE SHIELD | Cis-Us, Inc. | 1987-05-08 |
Legacy Summary#
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FDA Review#
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