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FDA 510(k)

MASTEL LASER CLEAN ROOM, MODEL EBS-100

K-Number: K043494 · 2005-10-04

ApplicantMastel Precision Surgical Instruments, Inc.
Decision Date2005-10-04
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MASTEL LASER CLEAN ROOM, MODEL EBS-100 is the device name listed in this FDA 510(k) record. The listed applicant is Mastel Precision Surgical Instruments, Inc.. It received FDA 510(k) clearance on 2005-10-04 under 510(k) number K043494. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASTEL LASER CLEAN ROOM, MODEL EBS-100?

MASTEL LASER CLEAN ROOM, MODEL EBS-100 is a medical device that received FDA 510(k) clearance on 2005-10-04. The listed applicant is Mastel Precision Surgical Instruments, Inc.. The 510(k) number is K043494.

When did MASTEL LASER CLEAN ROOM, MODEL EBS-100 receive FDA 510(k) clearance?

MASTEL LASER CLEAN ROOM, MODEL EBS-100 received FDA 510(k) clearance on 2005-10-04, under 510(k) number K043494.

Who is the listed applicant for MASTEL LASER CLEAN ROOM, MODEL EBS-100?

The FDA 510(k) record lists Mastel Precision Surgical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MASTEL LASER CLEAN ROOM, MODEL EBS-100?

The FDA product code for MASTEL LASER CLEAN ROOM, MODEL EBS-100 is FYD.

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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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