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510(k) K831568

RELIANCE TEMPO OPHTH. INSTR STAND by F. & F. Koenigkramer — Product Code HHF

K831568 is an FDA 510(k) premarket notification submitted by F. & F. Koenigkramer for the device "RELIANCE TEMPO OPHTH. INSTR STAND". The FDA issued a decision of Substantially Equivalent on June 30, 1983. The device falls under product code HHF (Remover, Intrauterine Device, Contraceptive, Hook-Type), a Class I device regulated under 21 CFR 884.4530. F. & F. Koenigkramer has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1983
Date Received
May 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Remover, Intrauterine Device, Contraceptive, Hook-Type
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by F. & F. Koenigkramer

  • K860519 — RELIANCE MODEL 200 PODIATRY CHAIR (February 19, 1986)
  • K853150 — RELIANCE 6100 (September 5, 1985)
  • K853149 — RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 (September 5, 1985)
  • K853151 — RELIANCE 5000 (September 5, 1985)
  • K843046 — RELIANCE TREATMENT CABINET (September 27, 1984)
  • K834060 — RELIANCE OPHTHALMIC SLIT LAMP R-083 (February 4, 1984)
  • K812544 — RELIANCE OPHTHALMIC INSTRUMENT CONTROL (September 21, 1981)
  • K761147 — RELIANCE MOD-U-LINE M-700 (January 28, 1977)

Other clearances for product code HHF

  • K926541 — IUD HOOKS (February 24, 1994)
  • K891030 — IUD HOOKS - SIMPLE, UNIVERSAL AND SKLAR (March 17, 1989)
  • K842295 — INTRAUTERINE DEVICE REMOVER (October 12, 1984)
  • K820115 — EMMETT IUD THREAD RETREIVER (February 5, 1982)
  • K811761 — THE EMMETT IUD THREAD RETRIEVER (September 21, 1981)

FDA data resources