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FDA 510(k)

LOSEFF BALLOON TYPE SELF-RETENTION WOUND

K-Number: K801349 · 1980-08-07

ApplicantLoseff Medical Designers, Ltd.
Decision Date1980-08-07
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LOSEFF BALLOON TYPE SELF-RETENTION WOUND is the device name listed in this FDA 510(k) record. The listed applicant is Loseff Medical Designers, Ltd.. It received FDA 510(k) clearance on 1980-08-07 under 510(k) number K801349. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOSEFF BALLOON TYPE SELF-RETENTION WOUND?

LOSEFF BALLOON TYPE SELF-RETENTION WOUND is a medical device that received FDA 510(k) clearance on 1980-08-07. The listed applicant is Loseff Medical Designers, Ltd.. The 510(k) number is K801349.

When did LOSEFF BALLOON TYPE SELF-RETENTION WOUND receive FDA 510(k) clearance?

LOSEFF BALLOON TYPE SELF-RETENTION WOUND received FDA 510(k) clearance on 1980-08-07, under 510(k) number K801349.

Who is the listed applicant for LOSEFF BALLOON TYPE SELF-RETENTION WOUND?

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

What is the FDA product code for LOSEFF BALLOON TYPE SELF-RETENTION WOUND?

The FDA product code for LOSEFF BALLOON TYPE SELF-RETENTION WOUND is JCX.

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Other records listing Loseff Medical Designers, Ltd. as applicant

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Official Source

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