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FDA 510(k)

SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS

K-Number: K893503 · 1989-06-12

Decision Date1989-06-12
Product CodeHFN
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS is the device name listed in this FDA 510(k) record. The listed applicant is Laurel Medical Corp.. It received FDA 510(k) clearance on 1989-06-12 under 510(k) number K893503. The device is classified under product code HFN. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS?

SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS is a medical device that received FDA 510(k) clearance on 1989-06-12. The listed applicant is Laurel Medical Corp.. The 510(k) number is K893503.

When did SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS receive FDA 510(k) clearance?

SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS received FDA 510(k) clearance on 1989-06-12, under 510(k) number K893503.

Who is the listed applicant for SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS?

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

What is the FDA product code for SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS?

The FDA product code for SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS is HFN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: HFN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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