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FDA 510(k)

ISOVOL-EXCHANGE TRAY

K-Number: K852167 · 1985-11-18

ApplicantRocky Mountain Medical Corp.
Decision Date1985-11-18
Product CodeBRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ISOVOL-EXCHANGE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Rocky Mountain Medical Corp.. It received FDA 510(k) clearance on 1985-11-18 under 510(k) number K852167. The device is classified under product code BRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOVOL-EXCHANGE TRAY?

ISOVOL-EXCHANGE TRAY is a medical device that received FDA 510(k) clearance on 1985-11-18. The listed applicant is Rocky Mountain Medical Corp.. The 510(k) number is K852167.

When did ISOVOL-EXCHANGE TRAY receive FDA 510(k) clearance?

ISOVOL-EXCHANGE TRAY received FDA 510(k) clearance on 1985-11-18, under 510(k) number K852167.

Who is the listed applicant for ISOVOL-EXCHANGE TRAY?

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

What is the FDA product code for ISOVOL-EXCHANGE TRAY?

The FDA product code for ISOVOL-EXCHANGE TRAY is BRZ.

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Other records listing Rocky Mountain Medical 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.

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Related Devices (Code: BRZ)

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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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