510(k) K912327
- Device
- DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS.
- Applicant
- DAVIS LEAD APRONS, INC.
- 510(k) number
- K912327
- Product code
- KPY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-18
- Date received
- 1991-05-24
- 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
- J. B DAVIS
- Address
- 1078 Curtin St. Houston TX US 77018 77018
FDA Registration Numbers#
- 3001970230
- 3026326493
- 2183301
- 3004845555
- 3009148458
- 1061124
- 3017956124
- 9680861
- 3045058049
- 3020118
- 3031184338
- 3021023132
- 3017220525
- 8043817
- 2134265
- 3012777736
- 3002806603
- 2182762
- 3031755043
- 1225473
- 3009688745
- 3015219076
- 3002532594
- 3011137372
- 8043304
- 2921581
- 3040389667
- 3007165189
- 2431224
- 1218386
- 1057495
- 3007699082
- 3014663932
- 3021970868
- 3033484057
- 3015058854
- 3027976674
- 3003887292
- 3004105221
- 3009222501
- 3003808764
- 3002124543
- 3005908723
- 9611112
- 3011529314
- 3008808560
- 3008264111
- 3014314985
- 3032027177
- 3010198795
- 3034669683
- 1932738
- 3005599545
- 3013260641
- 3043126854
- 3009540572
- 3011593607
- 3031590635
- 3014342658
- 3016758972
- 1450835
- 3014273526
- 3014700242
- 9616441
- 8022247
- 3012841710
- 9680506
- 3017636959
- 3016759113
- 3005579300
- 3026630
- 3010472281
- 3038134332
- 9710585
- 3010583458
- 3038966231
- 3017180923
- 3003000761
- 3011659880
- 3006621310
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 |
| 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 |
| K871502 | PERSONNEL PROTECTIVE SHIELD | Cis-Us, Inc. | 1987-05-08 |
Legacy Summary#
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FDA Review#
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