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510(k) K901530

WALLACE INTRAUTERINE INSEMINATION CATHETER by Gynescope Corp. — Product Code EJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1990
Date Received
April 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances by Gynescope Corp.

  • K902658 — GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES (September 19, 1990)
  • K902657 — GYNESCOPE LAPAROSCOPIC FORCEPS (September 19, 1990)
  • K902655 — GYNESCOPE LAPAROSCOPES (July 13, 1990)
  • K902656 — GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES (June 29, 1990)
  • K902019 — MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS (June 7, 1990)
  • K902049 — CROAK OVARIAN BIOPSY FORCEP (June 7, 1990)
  • K900878 — OTT INSUFFLATION FILTER TUBING (May 7, 1990)
  • K895225 — GYNECOLOGICAL INSTRUMENTATION (March 5, 1990)

Other clearances for product code EJT

  • K052463 — PROMETAL HN86 (October 14, 2005)
  • K041378 — BIO 60 (August 2, 2004)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K040043 — NDX-40 ALLOY (March 3, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, (March 1, 2004)
  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)