Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: SAULFON PW-70 A&B
• Classification Name: lenses, soft contact, extended wear
• Generic Name: soft lenses
• Regulation Number: 886.5925
• Applicant: VISIONTECH, INC.
• PMA Number: P840031
• Supplement Number: S003
• Date Received: 08/22/1985
• Decision Date: 03/17/1986
• Product Code: LPM [ Registered Establishments with LPM ]
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No