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510(k) K862496

MICROTEK INTRANASAL SPLINT by Microtek Medical, Inc. — Product Code EPP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1986
Date Received
July 1, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Nasal
Device Class
Class I
Regulation Number
874.5800
Review Panel
EN
Submission Type

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Other clearances for product code EPP

  • K942158 — AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS (July 29, 1994)
  • K942724 — EXTERNAL NASAL SPLINT (July 8, 1994)
  • K895502 — MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT (December 8, 1989)
  • K890599 — HOOD NASAL SPLINT (March 17, 1989)
  • K882244 — RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT (June 23, 1988)
  • K872905 — AMERICAN NASAL SPONGE (September 4, 1987)
  • K864932 — 'EXMOOR' CAWOOD NASAL SPLINTS (March 4, 1987)
  • K864933 — 'EXMOOR' SHAH & MACKAY NASAL SPLINTS (March 4, 1987)
  • K864930 — 'EXMOOR' ATKINS NASAL SPLINT (March 4, 1987)
  • K864934 — 'EXMOOR' SHAH SILICONE DISCS (January 28, 1987)