510(k) K830571
- Device
- BOTTLE ADAPTER
- Applicant
- BURRON MEDICAL PRODUCTS, INC.
- 510(k) number
- K830571
- Product code
- KYX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-24
- Date received
- 1983-02-23
- Regulation
- 880.6430
- Classification name
- Dispenser, Liquid Medication
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- 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#
- 3014662855
- 9611665
- 3039261408
- 3013434990
- 3009109684
- 3004727093
- 3008770655
- 1420054
- 3003310007
- 3021167963
- 3014312726
- 3030582179
- 3011270181
- 3011499367
- 3003805036
- 3013023255
- 3011050560
- 3016450032
- 3015277818
- 2031508
- 3038282348
- 3012030719
- 3005905524
- 3044026004
- 9616088
- 3010822231
- 2032112
- 3015168527
- 3039410557
- 2431166
- 3004598675
- 3002478693
- 1649518
- 3008432385
- 3012309743
- 3014314985
- 3007142798
- 3021207310
- 1319639
- 3011707926
- 1721676
- 3011279497
- 3008808082
- 3008138005
- 3039414397
- 3009881291
- 3004198398
- 2648727
- 2246552
- 3024999438
- 3010147274
- 2243072
- 3015895045
- 3045855232
- 2029015
- 3004099493
- 1422598
- 3009308092
- 1217805
- 3012416077
- 1213809
- 9681599
- 3012441761
- 1043214
- 3015534928
- 1018470
- 3013513780
- 3000214934
- 3012552122
- 3010753445
- 8010674
- 3010291427
- 3012429465
- 9610847
- 1217831
- 3038632739
- 2416455
- 3006210673
- 3017521274
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KYX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143177 | KleenGel Dispenser | Kleengel, LLC | 2015-09-14 |
| K980109 | CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER | Sangstat Medical Corp. | 1998-08-18 |
| K954181 | CANYONS BI-DIRECTIONAL CHECK VALVE | Canyon Medical Products | 1995-11-29 |
| K801008 | MULTI-AD FLUID DISPENSING PUMP MP-3000 | Burron Medical Products, Inc. | 1980-06-02 |
| K800362 | FLUID DISPENSING SYSTEM | Pharmaseal Laboratories | 1980-03-12 |
| K800437 | SYRINGE TIP CONNECTOR | Burron Medical Products, Inc. | 1980-03-12 |
| K792227 | MULTI-AD FLUID DISPENSING SYSTEM | National Patent Development Corp. | 1979-12-20 |
| K781364 | PINT BOTTLE WELL | Baxa Corp., Sub. of Cook Group, Inc. | 1978-10-17 |
| K771539 | STEPPER | Tridak | 1977-10-07 |
| K760517 | CUP, DISPOSABLE MEDICINE | Landmark Plastics | 1976-11-12 |
Legacy Summary#
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FDA Review#
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