SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION

Dressing, Wound, Drug

WINCHESTER LABORATORIES LLC.

The following data is part of a premarket notification filed by Winchester Laboratories Llc. with the FDA for Saljet Single Dose Sterile Saline Topical Solution.

Pre-market Notification Details

• Device ID: K993969
• 510k Number: K993969
• Device Name: SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
• Classification: Dressing, Wound, Drug
• Applicant: WINCHESTER LABORATORIES LLC. 325 NORTH WATER ST. Batavia, IL 60510
• Contact: Howard Rose
• Correspondent: Howard Rose; WINCHESTER LABORATORIES LLC. 325 NORTH WATER ST. Batavia, IL 60510
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-11-23
• Decision Date: 1999-12-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
40612479271294	K993969	000
60188151000000	K993969	000
00188151000008	K993969	000