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FDA 510(k)

SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536

K-Number: K901922 · 1990-10-26

ApplicantSafte S.P.A.
Decision Date1990-10-26
Product CodeEXN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 is the device name listed in this FDA 510(k) record. The listed applicant is Safte S.P.A.. It received FDA 510(k) clearance on 1990-10-26 under 510(k) number K901922. The device is classified under product code EXN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536?

SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 is a medical device that received FDA 510(k) clearance on 1990-10-26. The listed applicant is Safte S.P.A.. The 510(k) number is K901922.

When did SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 receive FDA 510(k) clearance?

SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 received FDA 510(k) clearance on 1990-10-26, under 510(k) number K901922.

Who is the listed applicant for SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536?

The FDA 510(k) record lists Safte S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536?

The FDA product code for SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 is EXN.

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Official Source

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