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510(k) K884781

OPTI-POINT by Plastic Injectors, Inc. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1989
Date Received
November 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

Other clearances by Plastic Injectors, Inc.

  • K863423 — CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100 (September 16, 1986)
  • K863374 — CODE-A-WELL SERIES 1-600, 1-625 (September 11, 1986)
  • K844058 — CODE-A-WALL SERIES 1-250 INOCULUM TRAY (November 13, 1984)
  • K842848 — CODE-A-WELL 350 MICROTITRATION STRIPS (September 7, 1984)
  • K841632 — CODE-A-WELL SERIES 200 PLATE (May 25, 1984)
  • K841937 — CODE-A-WELL SERIES 300 PLATE (May 22, 1984)
  • K841390 — CODE-A-WELL (May 2, 1984)

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