PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER
FDA 510(k) clearance K943836 · decided 1994-11-21
Clearance details
- K-number
- K943836
- Device name
- PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER
- Applicant
- Orion Life Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-05
- Decision date
- 1994-11-21
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- JOL
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Wheeling, 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 |
|---|
| STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 (K051370) | Baxter Healthcare Corp | 2005-08-12 |
| PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (K000266) | Primary Care Solutions, Inc. | 2001-07-12 |
| PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (K000265) | Primary Care Solutions, Inc. | 2001-07-12 |
| WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION (K003402) | Welcon, Inc. | 2001-05-01 |
| STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (K994321) | Automatic Liquid Packaging, Inc. | 2000-10-25 |
| HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (K974759) | Hydrox Laboratories | 1998-03-09 |
| HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (K974758) | Hydrox Laboratories | 1998-03-09 |
| STERILE SALINE FOR CATHETER CARE (K974397) | Baxter Healthcare Corp | 1998-02-10 |
| STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (K973734) | Welcon, Inc. | 1998-02-05 |
| GERM TRAPPER SUCTION TUBE HOLDER (K972372) | Rzv Medical Specialties, Inc. | 1997-12-11 |
| CPR SUCTION CATHETER KIT (K960216) | Custom Pack Reliability | 1996-04-15 |
| STERILE ISOTONIC SALINE & STERILE WATER (K954442) | Medcare Custom Packaging, Inc. | 1995-12-21 |
Recalls involving this device
No recalls on record reference this clearance.