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FDA 510(k)

APPLIC SYSTEM ACTIVATOR, ESPE

K-Number: K770941 · 1977-06-02

ApplicantEspe GmbH (Us)
Decision Date1977-06-02
Product CodeEID
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

APPLIC SYSTEM ACTIVATOR, ESPE is the device name listed in this FDA 510(k) record. The listed applicant is Espe GmbH (Us). It received FDA 510(k) clearance on 1977-06-02 under 510(k) number K770941. The device is classified under product code EID. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APPLIC SYSTEM ACTIVATOR, ESPE?

APPLIC SYSTEM ACTIVATOR, ESPE is a medical device that received FDA 510(k) clearance on 1977-06-02. The listed applicant is Espe GmbH (Us). The 510(k) number is K770941.

When did APPLIC SYSTEM ACTIVATOR, ESPE receive FDA 510(k) clearance?

APPLIC SYSTEM ACTIVATOR, ESPE received FDA 510(k) clearance on 1977-06-02, under 510(k) number K770941.

Who is the listed applicant for APPLIC SYSTEM ACTIVATOR, ESPE?

The FDA 510(k) record lists Espe GmbH (Us) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APPLIC SYSTEM ACTIVATOR, ESPE?

The FDA product code for APPLIC SYSTEM ACTIVATOR, ESPE is EID.

Related Clinical Trials

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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Other records listing Espe GmbH (Us) 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.

K925027PHOTAC-FIL APLICAPK913966SONO(R) -CEMK915005PHOTAC-BOND APLICAP, MODIFICATIONK913857ROCATEC(R) -PLUSK913965ESPE(R) -SILK905604VISIO-GEM ART-SYSTEM

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Related Devices (Code: EID)

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.

K941431BONE GRAFT DELIVERY SYRINGESBio-Interfaces, Inc.K913974ACCESS IMPRESSION BARRELCentrix, Inc.K873153CAULK'S VPS CARTRIDGE SYSTEMDentsply Intl.K871937IMPRESSION SYRINGEDentsply Intl.K863998COLTENE JET-MIXERColtene, Inc.K853282CENTRIX RIBBON TUBESCentrix, Inc.

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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