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510(k) K812895

YARMO NASAL CARTILAGE SOFTENER by American V. Mueller — Product Code KAE

K812895 is an FDA 510(k) premarket notification submitted by American V. Mueller for the device "YARMO NASAL CARTILAGE SOFTENER". The FDA issued a decision of Substantially Equivalent on November 2, 1981. The device falls under product code KAE (Forceps, Ent), a Class I device regulated under 21 CFR 874.4420. American V. Mueller has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1981
Date Received
October 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Ent
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by American V. Mueller

  • K873771 — HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (December 18, 1987)
  • K873332 — MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM (September 8, 1987)
  • K871685 — HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS (June 12, 1987)
  • K864676 — HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM (December 29, 1986)
  • K862772 — V. MUELLER (R) GOOSENECK CIRCULAR STAPLER (August 18, 1986)
  • K861471 — V. MUELLER VITAL CLIP-HEMOSTATIC CLIP (June 6, 1986)
  • K854568 — V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP (December 2, 1985)
  • K854049 — HEYER-SCHULTE SYRINGO PERITONEAL SHUNT (November 27, 1985)
  • K851082 — V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES (July 22, 1985)
  • K851974 — V. MUELLER VITAL SKIN STAPLER (June 11, 1985)

Other clearances for product code KAE

  • K853708 — LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE (February 14, 1986)
  • K851794 — 41-180 TO 41-246 VARIOUS NASAL FORCEPS (June 11, 1985)
  • K851795 — 41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS (June 11, 1985)
  • K851775 — 19-790 TO 19-1042 DRESSING/SPONGE FORCEPS (June 11, 1985)
  • K833608 — GOLD ALLIGATOR FORCEPS (January 11, 1984)
  • K833607 — MCGEE FORCEPS (January 3, 1984)
  • K833605 — CUPPED FORCEPS (January 3, 1984)
  • K822372 — OFFICE ECONO-FORCEPS (September 9, 1982)
  • K822369 — MICRO & MINI-MICRO ALLIGATOR FORCEPS (September 9, 1982)
  • K772397 — COTTLE COLUMELLA FORCEP (January 17, 1978)

FDA data resources