FDA 510(k)

FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW

K-Number: K102770 · 2010-12-21

Decision Date2010-12-21

Product CodeELW

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, LLC. It received FDA 510(k) clearance on 2010-12-21 under 510(k) number K102770. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW?

FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW is a medical device that received FDA 510(k) clearance on 2010-12-21. The listed applicant is Heraeus Kulzer, LLC. The 510(k) number is K102770.

When did FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW receive FDA 510(k) clearance?

FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW received FDA 510(k) clearance on 2010-12-21, under 510(k) number K102770.

Who is the listed applicant for FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW?

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

What is the FDA product code for FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW?

The FDA product code for FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW is ELW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.