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510(k) K811794

37% FORMALDEHYDE by Richard-Allan Medical Ind., Inc. — Product Code IGG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1981
Date Received
June 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Formaldehyde (Formalin, Formol)
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

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

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  • 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 IGG

  • K882268 — ZINC FORMALIN CONCENTRATE (June 15, 1988)
  • K861201 — FORMALDEHYDE SOLUTION, 37% (April 11, 1986)
  • K802506 — PLEASCENT OR FORMA-SCENT (November 12, 1980)
  • K792707 — PARA-PAK SAF (January 21, 1980)
  • K792705 — PARA-PAK FORMALIN (January 21, 1980)
  • K771201 — FORMALIN BUFFER CONCENTRATE (August 22, 1977)