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510(k) K780992

MILLARD MOUTH GAG by Nestor Engineering Associates, Inc. — Product Code KBN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1978
Date Received
June 14, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gag, Mouth
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Nestor Engineering Associates, Inc.

  • K780988 — DEVIN-NESTOR PNEUMATIC TOURNIQUET (October 3, 1978)
  • K780991 — PARALLEL BLADE MARKER (October 3, 1978)
  • K780990 — STAINLESS STEEL TEMPLATE (October 3, 1978)
  • K780989 — DEVIN-NESTOR SQUARE KNIFE (October 3, 1978)

Other clearances for product code KBN

  • K834540 — OP-CON SURGICAL INSTRUMENT #9 (March 6, 1984)
  • K822183 — MOUTH GAGS (August 16, 1982)