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510(k) K821705

NAGASHIMA F60MM ATTACH. LENS by Kelleher Corp. — Product Code FXQ

K821705 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "NAGASHIMA F60MM ATTACH. LENS". The FDA issued a decision of Substantially Equivalent on July 9, 1982. The device falls under product code FXQ (Lens, Camera, Surgical), a Class I device regulated under 21 CFR 878.4160. Kelleher Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1982
Date Received
June 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Camera, Surgical
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type

Other clearances by Kelleher Corp.

  • K822618 — EMERGENCY TRACHEOSTOMY INSTRUMENT SET (January 28, 1983)
  • K822268 — NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH (January 28, 1983)
  • K823083 — ELECTROSURGICAL UNIT (December 7, 1982)
  • K823111 — NYSTYMOGRAPH ACCESS (November 22, 1982)
  • K822252 — ENT TREATMENT UNITS (November 22, 1982)
  • K822272 — HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS (November 10, 1982)
  • K822017 — TYMPANOSTOMY TUBES & VARIOUS TYPES (October 27, 1982)
  • K822257 — VARIOUS TYPES OF LIGHT SOURCE HANDLES (October 26, 1982)
  • K822259 — LARYNGEAL SPATULAS (October 22, 1982)
  • K822004 — FACE SHIELDS (October 20, 1982)

FDA data resources