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FDA 510(k)

FIBER OPTIC HEADLIGHT #60-0765

K-Number: K802769 · 1980-12-11

ApplicantAspen Laboratories, Inc.
Decision Date1980-12-11
Product CodeFCT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FIBER OPTIC HEADLIGHT #60-0765 is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Laboratories, Inc.. It received FDA 510(k) clearance on 1980-12-11 under 510(k) number K802769. The device is classified under product code FCT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBER OPTIC HEADLIGHT #60-0765?

FIBER OPTIC HEADLIGHT #60-0765 is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K802769.

When did FIBER OPTIC HEADLIGHT #60-0765 receive FDA 510(k) clearance?

FIBER OPTIC HEADLIGHT #60-0765 received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802769.

Who is the listed applicant for FIBER OPTIC HEADLIGHT #60-0765?

The FDA 510(k) record lists Aspen Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIBER OPTIC HEADLIGHT #60-0765?

The FDA product code for FIBER OPTIC HEADLIGHT #60-0765 is FCT.

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Other records listing Aspen Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K981220SYSTEM 7500 ABC ELECTROSURGICAL UNITK963088SHEATH, ELECTROSURGICAL PENCILK955834SYSTEM 6500 ABC ELECTROSURGICAL UNITK9602964000 ETMK953081BEAMER PLUSK953007EXCALIBUR PLUS ELECTROSURGICAL UNIT

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Related Devices (Code: FCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960767LIGHT COMMANDERScieran Technologies, Inc.K924198MODIFIED SITE FIBER OPTIC MODULEChiron Vision Corp.K883480MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USESite Microsurgical Systems, Inc.K802770FIBER OPTIC HEADLIGHT #60-0766766Aspen Laboratories, Inc.K780433FIBER OPTIC ADJUSTABLE HEADLIGHTCameron-Miller, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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