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FDA 510(k)

STANDARD BREAST BOARDS; DELUXE BREAST BOARD

K-Number: K905007 · 1991-02-12

ApplicantBionix Development Corp.
Decision Date1991-02-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STANDARD BREAST BOARDS; DELUXE BREAST BOARD is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corp.. It received FDA 510(k) clearance on 1991-02-12 under 510(k) number K905007. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STANDARD BREAST BOARDS; DELUXE BREAST BOARD?

STANDARD BREAST BOARDS; DELUXE BREAST BOARD is a medical device that received FDA 510(k) clearance on 1991-02-12. The listed applicant is Bionix Development Corp.. The 510(k) number is K905007.

When did STANDARD BREAST BOARDS; DELUXE BREAST BOARD receive FDA 510(k) clearance?

STANDARD BREAST BOARDS; DELUXE BREAST BOARD received FDA 510(k) clearance on 1991-02-12, under 510(k) number K905007.

Who is the listed applicant for STANDARD BREAST BOARDS; DELUXE BREAST BOARD?

The FDA 510(k) record lists Bionix Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STANDARD BREAST BOARDS; DELUXE BREAST BOARD?

The FDA product code for STANDARD BREAST BOARDS; DELUXE BREAST BOARD is IYE.

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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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