OPTI-POINT

Laparoscope, Gynecologic (and Accessories)

PLASTIC INJECTORS, INC.

The following data is part of a premarket notification filed by Plastic Injectors, Inc. with the FDA for Opti-point.

Pre-market Notification Details

• Device ID: K884781
• 510k Number: K884781
• Device Name: OPTI-POINT
• Classification: Laparoscope, Gynecologic (and Accessories)
• Applicant: PLASTIC INJECTORS, INC. P.O. BOX 188 Spartanburg, SC 29304
• Contact: Burchette, Jr
• Correspondent: Burchette, Jr; PLASTIC INJECTORS, INC. P.O. BOX 188 Spartanburg, SC 29304
• Product Code: HET
• CFR Regulation Number: 884.1720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-11-15
• Decision Date: 1989-01-12