510(k) K781336
- Device
- SURGITEK DISPOSABLE FLO-RESTER
- Applicant
- MEDICAL ENGINEERING CORP.
- 510(k) number
- K781336
- Product code
- DWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-10-10
- Date received
- 1978-08-03
- Regulation
- 870.4500
- Classification name
- Instruments, Surgical, Cardiovascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- 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#
- 3010687973
- 3015542130
- 1319639
- 3015451162
- 3036795921
- 3013750125
- 1921846
- 9613083
- 1421879
- 8010769
- 3010455030
- 1423537
- 1412854
- 3003597504
- 3021680161
- 3003418325
- 1118880
- 2084346
- 3003431869
- 1220648
- 8010374
- 3005726885
- 3003687489
- 1061124
- 3008902714
- 3006950086
- 3006897899
- 9611617
- 8010298
- 8010300
- 9616088
- 3004111573
- 3042278955
- 3012507533
- 3003803182
- 2025587
- 9611273
- 9680519
- 2183319
- 8031015
- 3011636272
- 9611616
- 3012536737
- 1720929
- 1649139
- 9611813
- 8010877
- 9617604
- 2182208
- 2030624
- 1047843
- 8010422
- 3004608878
- 1056553
- 3029082594
- 3009051888
- 3015173212
- 3011175548
- 1058726
- 2320762
- 2020394
- 3035678069
- 1935627
- 9612086
- 3012448339
- 3009959868
- 3003244954
- 3016096142
- 2183570
- 3003882387
- 8010099
- 2015691
- 8043895
- 3013784566
- 1416666
- 1721676
- 1036836
- 3015970743
- 8010386
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DWS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022238 | MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 | Medtronic Vascular | 2002-10-09 |
| K964445 | OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) | Dlp, Inc. | 1997-01-30 |
| K962771 | BURKE CONGENITAL THORACOSCOPY INSTRUMENTS | Pilling Weck, Inc. | 1996-11-19 |
| K955689 | RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY | Contour Fabricators of Florida, Inc. | 1996-05-15 |
| K960139 | G.E. STERILE ANGIOGRAPHIC TRAY | GE Medical Systems | 1996-04-19 |
| K960144 | G.E. STERILE CT BIOPSY TRAY | GE Medical Systems | 1996-04-15 |
| K960143 | G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY | GE Medical Systems | 1996-04-09 |
| K934727 | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER | Cardiac Pacemakers, Inc. | 1994-01-10 |
| K900379 | HYCULT DIAMOND CORONARY BYPASS KNIFE | St. Jude Medical, Inc. | 1990-03-19 |
| K896307 | INSULATION PAD | Bio-Vascular, Inc. | 1990-01-19 |
| K894738 | MODEL 6888 LEAD TUNNELER | Cardiac Pacemakers, Inc. | 1989-09-13 |
| K892804 | NEWCHILL(TM) CARDIAC INSULATOR | Acacia Laboratories, Inc. | 1989-07-14 |
| K893436 | MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT | Pioneering Technologies, Inc. | 1989-07-14 |
| K891000 | MODIFIED EXTERNAL PAD | Instromedix, Inc. | 1989-05-19 |
| K890432 | DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) | Deknatel, Inc. | 1989-04-13 |
Legacy Summary#
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FDA Review#
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