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FDA 510(k)

MODIFICATION TO: SAVI APPLICATOR KIT

K-Number: K080565 · 2008-04-04

ApplicantCianna Medical, Inc.
Decision Date2008-04-04
Product CodeJAQ
Advisory CommitteeRA
DecisionUnknown

Device Summary

MODIFICATION TO: SAVI APPLICATOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cianna Medical, Inc.. It received FDA 510(k) clearance on 2008-04-04 under 510(k) number K080565. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the MODIFICATION TO: SAVI APPLICATOR KIT?

MODIFICATION TO: SAVI APPLICATOR KIT is a medical device that received FDA 510(k) clearance on 2008-04-04. The listed applicant is Cianna Medical, Inc.. The 510(k) number is K080565.

When did MODIFICATION TO: SAVI APPLICATOR KIT receive FDA 510(k) clearance?

MODIFICATION TO: SAVI APPLICATOR KIT received FDA 510(k) clearance on 2008-04-04, under 510(k) number K080565.

Who is the listed applicant for MODIFICATION TO: SAVI APPLICATOR KIT?

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

What is the FDA product code for MODIFICATION TO: SAVI APPLICATOR KIT?

The FDA product code for MODIFICATION TO: SAVI APPLICATOR KIT is JAQ.

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Other records listing Cianna Medical, 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.

K181007Cianna Medical SAVI Scout Reflector and SAVI Scout SystemK171767Cianna Medical SAVI Scout Reflector and SAVI Scout SystemK161507Cianna Medical SAVI Scout Reflector and SAVI Scout SystemK132463CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEMK101411SAVI PREPARATION DEVICEK081677SAVI APPLICATOR KIT

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Related Devices (Code: JAQ)

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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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