FDA 510(k)

JELFINE-52 (CODE NAME RD-0901)

K-Number: K981257 · 1998-08-13

Decision Date1998-08-13

Product CodeEJS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

JELFINE-52 (CODE NAME RD-0901) is the device name listed in this FDA 510(k) record. The listed applicant is J.F. Jelenko & Co., Inc.. It received FDA 510(k) clearance on 1998-08-13 under 510(k) number K981257. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JELFINE-52 (CODE NAME RD-0901)?

JELFINE-52 (CODE NAME RD-0901) is a medical device that received FDA 510(k) clearance on 1998-08-13. The listed applicant is J.F. Jelenko & Co., Inc.. The 510(k) number is K981257.

When did JELFINE-52 (CODE NAME RD-0901) receive FDA 510(k) clearance?

JELFINE-52 (CODE NAME RD-0901) received FDA 510(k) clearance on 1998-08-13, under 510(k) number K981257.

Who is the listed applicant for JELFINE-52 (CODE NAME RD-0901)?

The FDA 510(k) record lists J.F. Jelenko & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JELFINE-52 (CODE NAME RD-0901)?

The FDA product code for JELFINE-52 (CODE NAME RD-0901) is EJS.

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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.