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FDA 510(k)

MALIS SURGICAL LOUPES

K-Number: K874845 · 1987-12-23

ApplicantValley Forge Scientific Corp.
Decision Date1987-12-23
Product CodeHJH
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MALIS SURGICAL LOUPES is the device name listed in this FDA 510(k) record. The listed applicant is Valley Forge Scientific Corp.. It received FDA 510(k) clearance on 1987-12-23 under 510(k) number K874845. The device is classified under product code HJH. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MALIS SURGICAL LOUPES?

MALIS SURGICAL LOUPES is a medical device that received FDA 510(k) clearance on 1987-12-23. The listed applicant is Valley Forge Scientific Corp.. The 510(k) number is K874845.

When did MALIS SURGICAL LOUPES receive FDA 510(k) clearance?

MALIS SURGICAL LOUPES received FDA 510(k) clearance on 1987-12-23, under 510(k) number K874845.

Who is the listed applicant for MALIS SURGICAL LOUPES?

The FDA 510(k) record lists Valley Forge Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MALIS SURGICAL LOUPES?

The FDA product code for MALIS SURGICAL LOUPES is HJH.

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Other records listing Valley Forge Scientific Corp. 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.

K050364MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEMK042604VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTSK032601STRYKER INTERVENTIONAL PAIN RF GENERATORK033499MALIS IRRIGATION MODULE 1000K982229BI-DENTK973554VALLEY FORGE BIPOLAR BALL TIP ELECTRODE

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Related Devices (Code: HJH)

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.

K863983EXETER OPERATING LOUPEExeter Instruments, Inc.K830878BINOCULAR LOUPEAlmore Intl., 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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