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510(k) K792633

STERILIZATION PROCESS/OUTERWRAP by Procter & Gamble Mfg. Co. — Product Code KET

K792633 is an FDA 510(k) premarket notification submitted by Procter & Gamble Mfg. Co. for the device "STERILIZATION PROCESS/OUTERWRAP". The FDA issued a decision of Substantially Equivalent on January 11, 1980. The device falls under product code KET (Filters, Cell Collection, Tissue Processing), a Class I device regulated under 21 CFR 864.3010. Procter & Gamble Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1980
Date Received
December 19, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filters, Cell Collection, Tissue Processing
Device Class
Class I
Regulation Number
864.3010
Review Panel
PA
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)
  • K850940 — ALWAYS SUPER MAXIPAD-UNSCENTED (May 14, 1985)

Other clearances for product code KET

  • K875122 — DISPOSABLE STERILE SYRINGE FILTERS (January 12, 1988)
  • K870196 — PCTE MICROPOROUS MEMBRANE FILTER (May 12, 1987)
  • K844671 — CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON (February 25, 1985)
  • K840556 — DISPOSABLE SYRINGE FILTERS (March 5, 1984)

FDA data resources