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510(k) K944245

DYNABITE LAPAROSCOPIC FORCEPS by Portlyn Corp. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1994
Date Received
August 30, 1994
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 Portlyn Corp.

  • K970083 — DYNABITE HOT GI BIOPSY FORCEPS (June 17, 1997)
  • K951447 — DYNABITE CARDIOVASCULAR BIOPSY FORCEPS (July 27, 1995)
  • K952391 — DYNABITE UROLOGICAL FORCEPS (June 1, 1995)
  • K934506 — DYNABITE HYSTEROSCOPIC FORCEPS (March 22, 1994)
  • K901300 — BIOPSY FORCEPS (June 29, 1990)
  • K896147 — BIOPSY FORCEP (NON-ELECTRIC) (April 16, 1990)
  • K896146 — BIOPSY FORCEPS, (NON-RIGID) (March 9, 1990)

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