FDA 510(k)

REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1

K-Number: K082419 · 2009-05-27

Decision Date2009-05-27

Product CodeMQV

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 is the device name listed in this FDA 510(k) record. The listed applicant is Intra-Lock International, Inc.. It received FDA 510(k) clearance on 2009-05-27 under 510(k) number K082419. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1?

REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 is a medical device that received FDA 510(k) clearance on 2009-05-27. The listed applicant is Intra-Lock International, Inc.. The 510(k) number is K082419.

When did REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 receive FDA 510(k) clearance?

REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 received FDA 510(k) clearance on 2009-05-27, under 510(k) number K082419.

Who is the listed applicant for REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1?

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

What is the FDA product code for REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1?

The FDA product code for REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 is MQV.

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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.