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510(k) K770063

DISP. ABSORBENT COMPRESSED FIBRE WAFER by Lorvic Corp. — Product Code EFN

K770063 is an FDA 510(k) premarket notification submitted by Lorvic Corp. for the device "DISP. ABSORBENT COMPRESSED FIBRE WAFER". The FDA issued a decision of Substantially Equivalent on January 14, 1977. The device falls under product code EFN (Cotton, Roll), a Class I device regulated under 21 CFR 872.6050. Lorvic Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1977
Date Received
January 11, 1977
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 Lorvic Corp.

  • K871615 — U. V. GERMICIDAL UNIT (September 11, 1987)
  • K780263 — SHIELD (May 3, 1978)
  • K770064 — FLUORIDE GEL DISPOSABLE TRAY (January 14, 1977)
  • K760620 — SALIVA EJECTOR (September 21, 1976)
  • K760121 — IMPULSE HEAT SEALER (July 16, 1976)

Other clearances for product code EFN

  • K872810 — STRUNG DENTAL ROLLS (December 4, 1987)
  • K871464 — MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER (April 30, 1987)
  • K863764 — COTTON ROLLS, NON-STERILE (October 27, 1986)
  • 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)

FDA data resources