Home / 510(k) Clearances / K792625

510(k) K792625

STERILIZATION PROCESS/PLACENTA BASIN by Procter & Gamble Mfg. Co. — Product Code FNY

K792625 is an FDA 510(k) premarket notification submitted by Procter & Gamble Mfg. Co. for the device "STERILIZATION PROCESS/PLACENTA BASIN". The FDA issued a decision of Substantially Equivalent on January 16, 1980. The device falls under product code FNY (Basin, Emesis), a Class I device regulated under 21 CFR 880.6730. Procter & Gamble Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1980
Date Received
December 19, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Basin, Emesis
Device Class
Class I
Regulation Number
880.6730
Review Panel
HO
Submission Type

Other clearances by Procter & Gamble Mfg. Co.

  • K873457 — SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (January 19, 1988)
  • K873036 — ATTENDS INCONTINENT BRIEF (January 19, 1988)
  • K864673 — UNSCENTED MENSTRUAL PAD (January 21, 1987)
  • K861863 — MODIFIED PROTECTIVE GARMENT (August 11, 1986)
  • K862348 — SINGLE-USE PATIENT UNDERPAD (July 2, 1986)
  • K860598 — MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS (March 5, 1986)
  • K853880 — ATTENDS DISPOS. UNDERPAD (October 16, 1985)
  • K853000 — SCENTED ALWAYS PANTILINERS (September 6, 1985)
  • K852985 — UNSCENTED ALWAYS PANTILINERS (August 29, 1985)
  • K850955 — ALWAYS MAXIPADS - UNSCENTED (May 14, 1985)

Other clearances for product code FNY

  • K832826 — AAP DOSIMETRY RELEASE OR BASIN SETS (April 23, 1984)
  • K802538 — BASIN PACK (October 31, 1980)
  • K800440 — STERILE SPONGE BOWLS (April 29, 1980)
  • K771733 — 8 EMESIS BASIN (September 28, 1977)
  • K760494 — BASIN, ROUND WASH (November 12, 1976)
  • K760495 — BASIN, RECTANGULAR WASH (November 12, 1976)
  • K760492 — BASIN, LARGE OR SMALL (November 12, 1976)
  • K760085 — BASIN, STERILE (#3200) (July 20, 1976)

FDA data resources