510(k) K000266
- Device
- PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
- Applicant
- Primary Care Solutions, Inc.
- 510(k) number
- K000266
- Product code
- JOL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-07-12
- Date received
- 2000-01-28
- Regulation
- 880.6740
- Classification name
- Catheter And Tip, Suction
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- NORMAN RUEDT
- Address
- 339 Stonetown Rd. Ringwood NJ US 07456 07456
FDA Registration Numbers
- 1423537
- 3016685880
- 3011987967
- 3003674698
- 3014457631
- 3034669683
- 3010400865
- 3005809810
- 3010834934
- 3011547624
- 2936485
- 3016884033
- 1421101
- 3015895045
- 9680741
- 1054241
- 3019385708
- 1928237
- 3002808270
- 3016452400
- 3009756327
- 9680242
- 3010560653
- 1219930
- 3010455030
- 3003761012
- 3000247987
- 3017102971
- 3005160810
- 3006446479
- 8043467
- 2126670
- 2530138
- 3015416207
- 1820334
- 3018762668
- 3027645738
- 9612030
- 1061124
- 3017079526
- 3004911384
- 3030733800
- 3013513837
- 2320762
- 3009104075
- 9710058
- 9611610
- 3004215117
- 2210968
- 8010456
- 3002808022
- 3005528784
- 2429849
- 2028807
- 3004727093
- 3017171849
- 8010099
- 1317547
- 3017961114
- 3031184338
- 8040233
- 2183319
- 2032098
- 2249529
- 9615004
- 3008676146
- 3004464325
- 9614062
- 3006536657
- 3005669815
- 3011270181
- 3030447506
- 3007441485
- 8044099
- 3004056932
- 3014680149
- 3007137643
- 3007840839
- 3003836856
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JOL
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051370 | STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 | Baxter Healthcare Corp | 2005-08-12 |
| K000265 | PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION | Primary Care Solutions, Inc. | 2001-07-12 |
| K003402 | WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION | Welcon, Inc. | 2001-05-01 |
| K994321 | STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP | Automatic Liquid Packaging, Inc. | 2000-10-25 |
| K974759 | HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE | Hydrox Laboratories | 1998-03-09 |
| K974758 | HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE | Hydrox Laboratories | 1998-03-09 |
| K974397 | STERILE SALINE FOR CATHETER CARE | Baxter Healthcare Corp | 1998-02-10 |
| K973734 | STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION | Welcon, Inc. | 1998-02-05 |
| K972372 | GERM TRAPPER SUCTION TUBE HOLDER | Rzv Medical Specialties, Inc. | 1997-12-11 |
| K960216 | CPR SUCTION CATHETER KIT | Custom Pack Reliability | 1996-04-15 |
| K954442 | STERILE ISOTONIC SALINE & STERILE WATER | Medcare Custom Packaging, Inc. | 1995-12-21 |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Sherwood Medical Co. | 1995-12-15 |
| K951524 | THORACENTESIS CATHETER | Baxter Healthcare Corp | 1995-07-06 |
| K945728 | CATCO THORACIC CATHETER | Catco Medical, Inc. | 1995-05-23 |
| K943661 | STERILE PHYSIOLOGICAL SALINE/STERILE WATER | Medcare Custom Packaging, Inc. | 1995-04-10 |