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FDA 510(k)

RADOVAN SUBCUTANEOUS TISSUE EXPANDER

K-Number: K771224 · 1977-10-11

ApplicantHeyer Schulte Corp.
Decision Date1977-10-11
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

RADOVAN SUBCUTANEOUS TISSUE EXPANDER is the device name listed in this FDA 510(k) record. The listed applicant is Heyer Schulte Corp.. It received FDA 510(k) clearance on 1977-10-11 under 510(k) number K771224. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADOVAN SUBCUTANEOUS TISSUE EXPANDER?

RADOVAN SUBCUTANEOUS TISSUE EXPANDER is a medical device that received FDA 510(k) clearance on 1977-10-11. The listed applicant is Heyer Schulte Corp.. The 510(k) number is K771224.

When did RADOVAN SUBCUTANEOUS TISSUE EXPANDER receive FDA 510(k) clearance?

RADOVAN SUBCUTANEOUS TISSUE EXPANDER received FDA 510(k) clearance on 1977-10-11, under 510(k) number K771224.

Who is the listed applicant for RADOVAN SUBCUTANEOUS TISSUE EXPANDER?

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

What is the FDA product code for RADOVAN SUBCUTANEOUS TISSUE EXPANDER?

The FDA product code for RADOVAN SUBCUTANEOUS TISSUE EXPANDER is LCJ.

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Other records listing Heyer Schulte 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.

K7920962 FR KELMAN CHAMBER MAINTAINERK790842SUBCUTANEOUS TISSUE EXPANDERK780706LUMBAR NERVE ROOT SHIELDK780417ASEPTIC TRANSFER SETK760778T-TUBE DRAIN, ROUNDK760784MISHLER 2 CHAMB FLUSHING VALVE,STAND

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Related Devices (Code: LCJ)

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.

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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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