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510(k) K863764

COTTON ROLLS, NON-STERILE by The Medical Group, Inc. — Product Code EFN

K863764 is an FDA 510(k) premarket notification submitted by The Medical Group, Inc. for the device "COTTON ROLLS, NON-STERILE". The FDA issued a decision of Substantially Equivalent on October 27, 1986. The device falls under product code EFN (Cotton, Roll), a Class I device regulated under 21 CFR 872.6050. The Medical Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1986
Date Received
September 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cotton, Roll
Device Class
Class I
Regulation Number
872.6050
Review Panel
DE
Submission Type

Other clearances by The Medical Group, Inc.

  • K911246 — THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 (June 6, 1991)
  • K901295 — PULMONAIR 40 PATIENT MANAGEMENT SYSTEM (March 30, 1990)
  • K881843 — PEDIATRIC HOSPITAL BED (October 26, 1988)
  • K881844 — MAGNUM 800(TM) MANAGEMENT SYSTEM (July 14, 1988)
  • K870283 — 3 X 3 SPONGES, NON-STERILE (February 24, 1987)
  • K870282 — 4 X 4 SPONGES, NON-STERILE (February 24, 1987)
  • K870284 — TRIANGULAR BANDAGE (February 24, 1987)
  • K870285 — THERMOMETER SHEATHES, STERILE (GLASS) (February 12, 1987)
  • K863769 — EVACUATOR TIPS (October 30, 1986)
  • K863767 — GLASS MOUTH MIRRORS, REUSABLE (October 30, 1986)

Other clearances for product code EFN

  • K872810 — STRUNG DENTAL ROLLS (December 4, 1987)
  • K871464 — MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER (April 30, 1987)
  • K861338 — DENTAL COTTON ROLLS, STERILE AND NON-STERILE (August 6, 1986)
  • K861727 — COTTON FILLED GAUZE SPONGES 2 X 2 (July 10, 1986)
  • K843539 — TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- (May 23, 1985)
  • K841327 — DENTAL COTTON ROLLS (July 3, 1984)
  • K834056 — SCHEIN COTTON ROLLS, NON-STERILE (February 3, 1984)
  • K830175 — STERILE COTTON ROLLS #3, 1 1/2 (February 18, 1983)
  • K812709 — STERILE DENTAL ROLL (October 23, 1981)
  • K810830 — HOYT COTTON ROLLS (April 14, 1981)

FDA data resources