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510(k) K800162

ONCE TM by G.D. Searle and Co. — Product Code HDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1980
Date Received
January 25, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diaphragm, Contraceptive (And Accessories)
Device Class
Class II
Regulation Number
884.5350
Review Panel
OB
Submission Type

Other clearances by G.D. Searle and Co.

  • K821159 — IN-LINE OXYGEN MONITORING SYSTEM (May 25, 1982)
  • K811068 — BYPASS COIL (May 27, 1981)
  • K811071 — VENOUS OXYGEN PROBE (May 5, 1981)
  • K803238 — INTRAVASCULAR CATHETER (April 23, 1981)
  • K810630 — SILICONE ELASTOMER COATED LATEX FOLEY (March 31, 1981)
  • K810131 — ADMINISTRATION SET (February 26, 1981)
  • K802485 — SEARLE VASCULAR LOOPS (February 12, 1981)
  • K801805 — METRONIDAZOLE DISCS (February 10, 1981)
  • K810112 — SWR DISPOSABLE PREP RAZOR (February 4, 1981)
  • K802213 — WHITE KNIGHT BOVIE CORD/SUCTION TUBE (October 10, 1980)

Other clearances for product code HDW

  • K140305 — CAYA CONTOURED DIAPHRAGM (August 26, 2014)
  • K080040 — ORTHO ALL-FLEX DIAPHRAGM (August 25, 2008)
  • K063223 — MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL (January 23, 2008)