510(k) K811068
- Device
- BYPASS COIL
- Applicant
- G.D. SEARLE AND CO.
- 510(k) number
- K811068
- Product code
- KPY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-05-27
- Date received
- 1981-04-17
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3015058854
- 3014466582
- 3008808560
- 3009688745
- 3001970230
- 3013443304
- 3005257704
- 3017496466
- 3040389667
- 8043817
- 1037577
- 3013285519
- 3003000761
- 3002806603
- 3043535425
- 9710585
- 3031167704
- 3042989733
- 2124215
- 3031184338
- 9615270
- 3027617478
- 3040391047
- 2087075
- 2921581
- 3003808764
- 2247992
- 3020824984
- 3023152124
- 3008005217
- 3007369190
- 3029900933
- 3013394380
- 3014273526
- 3043648115
- 3002532594
- 3004845555
- 3017180923
- 1222742
- 1225691
- 3008044484
- 3015219076
- 3012395063
- 3016147813
- 3010041511
- 3012184208
- 3017956124
- 3016426851
- 3013575574
- 3014644369
- 3038282968
- 3033484057
- 3017397209
- 2182762
- 3003768277
- 3021023132
- 3011526299
- 3026030534
- 3017896194
- 8030607
- 3011659880
- 3031755043
- 1057495
- 1928237
- 3009420946
- 9680506
- 3011253868
- 3011137372
- 8022247
- 3038134332
- 3007069733
- 3008931233
- 3045058049
- 3011344631
- 3016763307
- 1932668
- 3026630
- 3010827261
- 3010147274
- 9680861
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 |
| 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 |
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