PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION (K082330) - FDA 510(k) Clearance

K082330 is an FDA 510(k) clearance for the PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Primary Care Solutions, Inc. (Zephyrhills, US). The FDA issued a Cleared decision on October 9, 2008 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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