510(k) K962622
- Device
- INTRA-ORAL THERMOPLASTIC SHIELD
- Applicant
- MEDTEC, INC.
- 510(k) number
- K962622
- Product code
- KPY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-01
- Date received
- 1996-07-05
- 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
- DONALD F RIIBE
- Address
- 1401 8th St., SE P.O. Box 320 Orange City IA US 51041 51041
FDA Registration Numbers#
- 3021970868
- 3013374101
- 3025001668
- 1314417
- 3005579300
- 3040391047
- 3003000761
- 3031167704
- 9680861
- 1225691
- 3020118
- 3034669683
- 3013646819
- 1836161
- 3003967959
- 3005022483
- 3017956124
- 3006621310
- 3011526299
- 1053541
- 3007069733
- 3000174892
- 3014819517
- 3009688745
- 3012395063
- 3016948452
- 3031755043
- 3008264111
- 3038632739
- 3009420946
- 3015532203
- 3013070673
- 1820334
- 3016739098
- 3011310668
- 2134265
- 3013260641
- 2529126
- 9615270
- 3014466582
- 3005908723
- 3027617478
- 3027976674
- 3010198795
- 3003768277
- 1048735
- 9710585
- 3009088444
- 3015219076
- 3013285519
- 3014342658
- 3007255375
- 8043542
- 3032027177
- 2247992
- 3012690638
- 1037577
- 3016989300
- 3005257704
- 3007369190
- 3014700242
- 3004105221
- 3023152124
- 2182762
- 3010583458
- 9680506
- 3016872092
- 1450835
- 3031590635
- 3008808560
- 2184007
- 3008427684
- 3013575574
- 1644312
- 3003887292
- 3005785003
- 3007699082
- 3007594755
- 3011344631
- 3031184338
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 |
| 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 |
| 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#
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
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