DYNASOL (R) PRESERVATIVE-FREE SALINE SOLUTION

Accessories, Soft Lens Products

FDA Premarket Approval P880080 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

• Device: DYNASOL (R) PRESERVATIVE-FREE SALINE SOLUTION
• Classification Name: Accessories, Soft Lens Products
• Generic Name: Accessories, Soft Lens Products
• Applicant: STERIDYNE LABORATORIES, INC.
• Date Received: 1989-01-01
• Decision Date: 1989-08-28
• PMA: P880080
• Supplement: S001
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: STERIDYNE LABORATORIES, INC. 22 Hillwood Rd. east Brunswick, NJ 08816

Supplemental Filings

Supplement Number	Date	Supplement Type
P880080		Original Filing
S004	1991-01-02	Normal 180 Day Track
S003
S002	1989-08-10	Normal 180 Day Track
S001	1989-01-01	Normal 180 Day Track