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510(k) K771615

AUDI-SIL EARMOLD MATERIAL by Coe Laboratories, Inc. — Product Code ESH

K771615 is an FDA 510(k) premarket notification submitted by Coe Laboratories, Inc. for the device "AUDI-SIL EARMOLD MATERIAL". The FDA issued a decision of Substantially Equivalent on August 30, 1977. The device falls under product code ESH (Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane), a Class II device regulated under 21 CFR 874.3620. Coe Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1977
Date Received
August 24, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Other clearances by Coe Laboratories, Inc.

  • K903292 — ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS (October 19, 1990)
  • K894282 — FIRST IMPRESSION TM (December 22, 1989)
  • K894281 — FIRST IMPRESSION WITH CHLORHEXIDINE (September 26, 1989)
  • K891140 — OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT (May 1, 1989)
  • K885010 — TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING (February 13, 1989)
  • K881422 — COE PAK AUTO MIX, REGULAR OR HARD SET (October 31, 1988)
  • K881091 — OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL (June 28, 1988)
  • K863882 — OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE (November 18, 1986)
  • K842877 — ABSOLUTE VINYL POLYSILOXANE IMPRESS (March 11, 1985)
  • K844325 — COE-LITE POLYMERIZATION UNIT (December 11, 1984)

FDA data resources