CATHETER IRRIGATION TRAYS, #3300, 3310 &
FDA 510(k) clearance K801783 · decided 1980-08-13
Clearance details
- K-number
- K801783
- Device name
- CATHETER IRRIGATION TRAYS, #3300, 3310 &
- Applicant
- The Healthcare Group Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-07-28
- Decision date
- 1980-08-13
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- EYN
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IRRIGATION TRAY (K944882) | Clinical Resources, Inc. | 1995-01-12 |
| IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE (K923941) | American Healthcare Corp. | 1993-06-17 |
| IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER (K923939) | American Healthcare Corp. | 1993-06-17 |
| IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER (K923938) | American Healthcare Corp. | 1993-06-17 |
| IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE (K923940) | American Healthcare Corp. | 1993-06-17 |
| KIT PAK IRRIGATION TRAY (K900148) | Kit Pak, Inc. | 1990-04-23 |
| PISTON IRRIGATION TRAY (K900737) | Orion Life Systems, Inc. | 1990-04-19 |
| BULB IRRIGATION TRAY (K900736) | Orion Life Systems, Inc. | 1990-04-17 |
| GAVAGE FEEDING SET (K792082) | Medical Devices, Inc. | 1979-11-13 |
| FLUID ADMINISTRATION SET FA-3160 (K791020) | Burron Medical Products, Inc. | 1979-06-27 |
| GREENLINE IRRIGATION TRAYS (K790607) | Snyder Laboratories, Inc. | 1979-05-11 |
| IRRIGATOR, BODY CAVITY (K781918) | Bci, Inc. | 1979-02-15 |
Recalls involving this device
No recalls on record reference this clearance.