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FDA 510(k)

TENTATIVELY POLARUS EX ROD

K-Number: K952534 · 1995-07-13

ApplicantAcu-Med, Inc.
Decision Date1995-07-13
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TENTATIVELY POLARUS EX ROD is the device name listed in this FDA 510(k) record. The listed applicant is Acu-Med, Inc.. It received FDA 510(k) clearance on 1995-07-13 under 510(k) number K952534. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENTATIVELY POLARUS EX ROD?

TENTATIVELY POLARUS EX ROD is a medical device that received FDA 510(k) clearance on 1995-07-13. The listed applicant is Acu-Med, Inc.. The 510(k) number is K952534.

When did TENTATIVELY POLARUS EX ROD receive FDA 510(k) clearance?

TENTATIVELY POLARUS EX ROD received FDA 510(k) clearance on 1995-07-13, under 510(k) number K952534.

Who is the listed applicant for TENTATIVELY POLARUS EX ROD?

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

What is the FDA product code for TENTATIVELY POLARUS EX ROD?

The FDA product code for TENTATIVELY POLARUS EX ROD is HSB.

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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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