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FDA 510(k)

ABIODENT PERIOTEMP(R) SYSTEM

K-Number: K911643 · 1991-07-09

ApplicantAbiomed, Inc.
Decision Date1991-07-09
Product CodeEIL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ABIODENT PERIOTEMP(R) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 1991-07-09 under 510(k) number K911643. The device is classified under product code EIL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABIODENT PERIOTEMP(R) SYSTEM?

ABIODENT PERIOTEMP(R) SYSTEM is a medical device that received FDA 510(k) clearance on 1991-07-09. The listed applicant is Abiomed, Inc.. The 510(k) number is K911643.

When did ABIODENT PERIOTEMP(R) SYSTEM receive FDA 510(k) clearance?

ABIODENT PERIOTEMP(R) SYSTEM received FDA 510(k) clearance on 1991-07-09, under 510(k) number K911643.

Who is the listed applicant for ABIODENT PERIOTEMP(R) SYSTEM?

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

What is the FDA product code for ABIODENT PERIOTEMP(R) SYSTEM?

The FDA product code for ABIODENT PERIOTEMP(R) SYSTEM is EIL.

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Other records listing Abiomed, 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.

K25276614Fr Low Profile Introducer KitK241708Abiomed 14Fr Low Profile Introducer KitK221294preCARDIA Occlusion SystemK223161OXY-1 SystemK222113Abiomed 14Fr Low Profile Introducer SetK202330Impella XR Sheath Set

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Related Devices (Code: EIL)

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.

K890493FLORIDA PROBE PERIODONTAL PROBEFlorida Probe Corp.K885075ABIOMED PERIOTEMP(TM) PROBEAbiomed, Inc.K884813MODEL 200A ELECTRONIC FORCE-SENSING PROBEVine Valley ResearchK880209PERIODONTAL PROBE - AUTOPROBEDentsply Intl.K872098CREMEEN ALVEOLAR BONE CALIPERBowen & Company, Inc.K872215PERIO-TESTDr. Bernard Loewenthal

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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