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510(k) K812847

XYLENE by Richard-Allan Medical Ind., Inc. — Product Code KEM

K812847 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical Ind., Inc. for the device "XYLENE". The FDA issued a decision of Substantially Equivalent on October 29, 1981. The device falls under product code KEM (Agent, Clearing), a Class I device regulated under 21 CFR 864.4010. Richard-Allan Medical Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1981
Date Received
October 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Clearing
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Richard-Allan Medical Ind., Inc.

  • K931879 — REFLEX HTR (March 24, 1994)
  • K924200 — REFLEX(R) ESC (February 22, 1994)
  • K926297 — REFLEX ESI (October 15, 1993)
  • K924761 — STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD (April 20, 1993)
  • K900566 — RICHARD-ALLAN VESSEL LOOPS (May 3, 1990)
  • K896262 — TITANIUM LIGATING CLIPS (January 2, 1990)
  • K890314 — PROTECTOR (SURGICAL INSTRUMENT) (February 27, 1989)
  • K873309 — REFLEX(TM) CA-T CLIP APPLIER (November 27, 1987)
  • K862404 — REFLEX(TM) CLIP APPLIER (July 23, 1986)
  • K862223 — MICRO THIN* PARAFFIN (June 17, 1986)

Other clearances for product code KEM

  • K881282 — XYLENE (April 5, 1988)
  • K874461 — HEMO-SOL (December 4, 1987)
  • K861490 — PERMACLEAR SOLUTION CAT. NO. 4950 (May 6, 1986)
  • K855109 — CLEARENE, CLEARING AGENT (January 7, 1986)
  • K854083 — XYLENE SUBSTITUTE MONTANT (October 22, 1985)
  • K853694 — XYLENE SUBSTITUTE (October 22, 1985)
  • K842861 — PRO-PAR CLEARANT (August 21, 1984)
  • K842721 — LIMONENE (August 3, 1984)
  • K832451 — CLEAR-RITE 3 (August 12, 1983)
  • K832011 — AMERI CLEAR (August 12, 1983)

FDA data resources