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510(k) K792629

STERILIZATION PROCESS/T-BINDER by Procter & Gamble Mfg. Co. — Product Code KMO

K792629 is an FDA 510(k) premarket notification submitted by Procter & Gamble Mfg. Co. for the device "STERILIZATION PROCESS/T-BINDER". The FDA issued a decision of Substantially Equivalent on January 11, 1980. The device falls under product code KMO (Binder, Elastic), a Class I device regulated under 21 CFR 880.5160. 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
Binder, Elastic
Device Class
Class I
Regulation Number
880.5160
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 KMO

  • K921852 — 4 SURE TM RECTAL TUBE (October 8, 1993)
  • K893809 — COUGH PILLOW (August 28, 1989)
  • K883214 — THORACIC SUPPORT SYSTEM (January 17, 1989)
  • K882592 — HEART HUGGER STERNUM SUPPORT HARNESS (September 20, 1988)

FDA data resources