510(k) K791020
- Device
- FLUID ADMINISTRATION SET FA-3160
- Applicant
- BURRON MEDICAL PRODUCTS, INC.
- 510(k) number
- K791020
- Product code
- EYN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-06-27
- Date received
- 1979-06-01
- Regulation
- 876.5980
- Classification name
- Tray, Irrigation, Sterile
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General & Plastic Surgery
- 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#
- 1928237
- 3015173212
- 1319639
- 3004122598
- 3005012805
- 1057358
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EYN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944882 | IRRIGATION TRAY | Clinical Resources, Inc. | 1995-01-12 |
| K923938 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER | American Healthcare Corp. | 1993-06-17 |
| K923939 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER | American Healthcare Corp. | 1993-06-17 |
| K923940 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE | American Healthcare Corp. | 1993-06-17 |
| K923941 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE | American Healthcare Corp. | 1993-06-17 |
| K900148 | KIT PAK IRRIGATION TRAY | Kit Pak, Inc. | 1990-04-23 |
| K900737 | PISTON IRRIGATION TRAY | Orion Life Systems, Inc. | 1990-04-19 |
| K900736 | BULB IRRIGATION TRAY | Orion Life Systems, Inc. | 1990-04-17 |
| K801783 | CATHETER IRRIGATION TRAYS, #3300, 3310 & | The Healthcare Group Laboratories, Inc. | 1980-08-13 |
| K792082 | GAVAGE FEEDING SET | Medical Devices, Inc. | 1979-11-13 |
| K790607 | GREENLINE IRRIGATION TRAYS | Snyder Laboratories, Inc. | 1979-05-11 |
| K781918 | IRRIGATOR, BODY CAVITY | Bci, Inc. | 1979-02-15 |
| K781748 | IRRIGATION TRAY | Intermed, Inc. | 1978-12-12 |
| K760047 | TRAY, BLADDER IRRIGATION | M-C Ind., Inc. | 1977-03-01 |
Legacy Summary#
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FDA Review#
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