510(k) K954146
- Device
- UTK-DTE AUTILARY SHIELD
- Applicant
- MALLINCKRODT MEDICAL
- 510(k) number
- K954146
- Product code
- KPY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-12-06
- Date received
- 1995-09-05
- 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
- MICHAEL B SCHOECK
- Address
- 675 Mcdonnell Blvd. P.O. Box 5840 St Louis MO US 63134 63134
FDA Registration Numbers#
- 3005785003
- 3008005217
- 3023152124
- 8022247
- 3005022483
- 3020824984
- 9680506
- 3014663932
- 1219183
- 1820334
- 3003965134
- 3014466582
- 3002532594
- 3009540572
- 2921581
- 2518443
- 3021023132
- 3003887292
- 3009222501
- 1048735
- 2939388
- 3007069733
- 3002806603
- 9616441
- 3003000761
- 3038966231
- 3010353405
- 3007255375
- 3010583458
- 3009088444
- 3016763307
- 1314417
- 3013394380
- 3027976674
- 3017180923
- 1222742
- 1225473
- 3040389667
- 2025851
- 3014700242
- 3011659880
- 3009420946
- 3043535425
- 3016257387
- 3006621310
- 3032027177
- 3034565743
- 3008427684
- 3040391047
- 3010472281
- 1932668
- 2087075
- 1928237
- 3003768277
- 3038282968
- 3007699082
- 3011526299
- 3012395063
- 3011529314
- 1061124
- 2182762
- 9680861
- 3011593607
- 3014644369
- 3010198795
- 3016159368
- 3030194786
- 3009148458
- 3016937081
- 1121142
- 3027617478
- 3016872092
- 9710585
- 3043009869
- 2134265
- 3016147813
- 3005607112
- 1825146
- 2431224
- 3020118
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 |
| 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 |
| 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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases