510(k) K821703
- Device
- MGN CONDUCTIVE CONNECTING TUBE, STERILE
- Applicant
- MGN MEDICAL MANUFACTURING, INC.
- 510(k) number
- K821703
- Product code
- BYY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-06-22
- Date received
- 1982-06-02
- Regulation
- 880.6740
- Classification name
- Tube, Aspirating, Flexible, Connecting
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3042989733
- 3013557562
- 3009104075
- 9710524
- 3010131137
- 1926681
- 1319639
- 3008280196
- 3016950436
- 3017961114
- 3018762668
- 3004530184
- 8040233
- 1054241
- 9612030
- 3034602341
- 3013298431
- 3030977779
- 9615050
- 3014810929
- 3016171914
- 3005580113
- 3014615175
- 3023141635
- 3034669683
- 3044563261
- 3017886332
- 3013550220
- 3009349165
- 8043817
- 3011529314
- 1417592
- 2246552
- 3016733629
- 3031190571
- 2320762
- 3002858762
- 3011193403
- 3042277643
- 2029214
- 3013530405
- 3022106572
- 1018470
- 3008719017
- 3007007790
- 3006542380
- 3002821232
- 3013319212
- 9614279
- 3007456622
- 3003902679
- 3011707784
- 3032747418
- 3003431869
- 3021009035
- 1824619
- 3011716786
- 3017636737
- 3004777218
- 3004519921
- 3013226
- 1422634
- 3012660022
- 3012568936
- 9616083
- 2183650
- 1313525
- 3012494290
- 3010202439
- 3006617533
- 3044150131
- 1043214
- 3018503755
- 3011094311
- 3006142527
- 3045058049
- 3006673317
- 8022210
- 9616419
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BYY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960616 | VITAFLOW SUCTION/ASPIRATION TUBING SET | Vital Concepts, Inc. | 1996-05-06 |
| K960218 | CONNECTING TUBING | Custom Pack Reliability | 1996-03-28 |
| K955149 | MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL | Bio-Medical Devices, Inc. | 1996-01-24 |
| K955151 | MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR | Bio-Medical Devices, Inc. | 1996-01-24 |
| K955150 | MAXI-FLOW | Bio-Medical Devices, Inc. | 1996-01-23 |
| K922989 | WILTEK IRRIGAITON/ASPIRATION TUBE SET | Wiltek Medical, Inc. | 1994-02-15 |
| K911586 | GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC) | Megadyne Medical Products, Inc. | 1991-07-02 |
| K901761 | STERILE SUCTION TUBING SET | Acacia Laboratories, Inc. | 1990-05-07 |
| K873463 | VAN DELLEN ASPIRATING TUBING | Van Dellen, Ltd. | 1987-11-23 |
| K853296 | EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN | Parexel Intl. Corp. | 1985-08-15 |
| K843470 | PHARMA-PLAST CONNECTING TUBE TYPE SUCT- | Zimmar Consulting , Ltd. | 1984-11-16 |
| K832865 | FLEX BUBBLE TUBING | Sheridan Catheter Corp. | 1983-09-29 |
| K832398 | DYNACOR CONNECTING TUBING | Medline Industries, Inc. | 1983-08-24 |
| K831920 | PLASTIC TUBING CONNECTORS | Polymer Technology Corp. | 1983-07-19 |
| K820371 | PLASTIC CONNECTORS | American Pharmaseal Div. Ahsc | 1982-04-01 |
Legacy Summary#
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FDA Review#
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