FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
K Number: K082330
·
Decision Oct 9, 2008
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
4
Review Days
56
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Basic Information
- Device Name
- PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
- K Number
- K082330
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Primary Care Solutions, Inc.
- Date Received
- August 14, 2008
- Decision Date
- October 9, 2008
- Product Code
- FRO
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Primary Care Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030813 | PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND | May 30, 2003 | Substantially Equivalent |
| K000265 | PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION | Jul 12, 2001 | Substantially Equivalent |
| K000266 | PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION | Jul 12, 2001 | Substantially Equivalent |