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FDA 510(k)

PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON

K-Number: K122503 · 2013-06-25

ApplicantNeuro Therm, Inc.
Decision Date2013-06-25
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Neuro Therm, Inc.. It received FDA 510(k) clearance on 2013-06-25 under 510(k) number K122503. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON?

PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON is a medical device that received FDA 510(k) clearance on 2013-06-25. The listed applicant is Neuro Therm, Inc.. The 510(k) number is K122503.

When did PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON receive FDA 510(k) clearance?

PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON received FDA 510(k) clearance on 2013-06-25, under 510(k) number K122503.

Who is the listed applicant for PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON?

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

What is the FDA product code for PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON?

The FDA product code for PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON is NDN.

Related Clinical Trials

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Other records listing Neuro Therm, 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.

K111576NT 2000 LESIONING GENERATORK052878NT-1000

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Official Source

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