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510(k) K782002

TRACH-COLLAR by Kinetic Concepts, Inc. — Product Code EQN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 15, 1978
Date Received: December 4, 1978
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Laryngoscope, Nasopharyngoscope
Device Class: Class II
Regulation Number: 874.4760
Review Panel: EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Kinetic Concepts, Inc.

K050261 — V.A.C. GRANUFOAM SILVER PROTECTION DRESSING (May 26, 2005)
K041642 — V.A.C. GRANUFOAM SILVER DRESSING (January 25, 2005)
K032310 — MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS (October 10, 2003)
K022011 — V.A.C. ABDOMINAL DRESSING (February 26, 2003)
K021500 — VACUUM ASSISTED CLOSURE (December 20, 2002)
K021501 — V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT (December 2, 2002)
K020781 — WET CHAMBER (May 6, 2002)
K992448 — V.A.C. PLUS (January 18, 2000)
K972176 — HOME CARE BEAD BED (January 16, 1998)
K972549 — SIMPULSE (November 18, 1997)

Other clearances for product code EQN

K150248 — ORL Video NasoPharyngo-Larngoscope (July 23, 2015)
K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM (February 21, 2014)
K834172 — OP-CON SURG. INSTRUMENT #7 (March 6, 1984)
K831255 — LARYNGOSCOPE ATTACHMENT PH2000 (September 12, 1983)
K830888 — COOL-LITE FIBERCOPTIC LARYNGEAL EXAM (April 27, 1983)
K822525 — LARYNGOSCOPES RIGID (September 9, 1982)
K821710 — NAGASHIMA NX-150F LIGHT SOURCE UNIT (June 25, 1982)
K821707 — NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT (June 25, 1982)
K821706 — NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL (June 25, 1982)
K821708 — NAGASHIMA LIGHT SOURCE UNIT SL-4 (June 25, 1982)