OPHTHALMIC SURGICAL SPECULUM— 510(k) K863664

Substantially Equivalent

Myocure, Inc.

FDA 510(k) clearance K863664 for OPHTHALMIC SURGICAL SPECULUM, Substantially Equivalent on 1986-09-25. Applicant: Myocure, Inc.. Device class: 1.

Clearance details

Applicant: Myocure, Inc.
Product code: Code HNC
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1986-09-18
Decision date: 1986-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HNC

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K964289 — EYE FIXATION SPECULUM1996-12-17
K863989 — THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)1986-10-31
K843196 — VISITEC EYE SPECULUM1984-10-05

More clearances from Myocure, Inc.

K880345 — CYSTOTOMES/KNIFES1988-05-03
K880346 — CANNULAS1988-05-03
K880347 — ANESTHESIA/RETROBULBAR NEEDLES1988-05-03
K874057 — OPHTHALMIC TIP & BLADE SCALPELS1987-12-23
K874056 — OPHTHALMIC DISPOSABLE BLADES1987-12-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.