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FDA 510(k)

BIOCARE SYSTEMS PREMIR 818

K-Number: K042532 · 2004-12-13

ApplicantBiocare Systems, Inc.
Decision Date2004-12-13
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIOCARE SYSTEMS PREMIR 818 is the device name listed in this FDA 510(k) record. The listed applicant is Biocare Systems, Inc.. It received FDA 510(k) clearance on 2004-12-13 under 510(k) number K042532. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCARE SYSTEMS PREMIR 818?

BIOCARE SYSTEMS PREMIR 818 is a medical device that received FDA 510(k) clearance on 2004-12-13. The listed applicant is Biocare Systems, Inc.. The 510(k) number is K042532.

When did BIOCARE SYSTEMS PREMIR 818 receive FDA 510(k) clearance?

BIOCARE SYSTEMS PREMIR 818 received FDA 510(k) clearance on 2004-12-13, under 510(k) number K042532.

Who is the listed applicant for BIOCARE SYSTEMS PREMIR 818?

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

What is the FDA product code for BIOCARE SYSTEMS PREMIR 818?

The FDA product code for BIOCARE SYSTEMS PREMIR 818 is ILY.

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Other records listing Biocare Systems, 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.

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Official Source

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