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FDA 510(k)

LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY

K-Number: K963076 · 1997-04-04

ApplicantLouisville Laboratories, Inc.
Decision Date1997-04-04
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Louisville Laboratories, Inc.. It received FDA 510(k) clearance on 1997-04-04 under 510(k) number K963076. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY?

LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY is a medical device that received FDA 510(k) clearance on 1997-04-04. The listed applicant is Louisville Laboratories, Inc.. The 510(k) number is K963076.

When did LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY receive FDA 510(k) clearance?

LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY received FDA 510(k) clearance on 1997-04-04, under 510(k) number K963076.

Who is the listed applicant for LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY?

The FDA 510(k) record lists Louisville Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY?

The FDA product code for LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY is HET.

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Other records listing Louisville Laboratories, Inc. as applicant

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.

K980123CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SETK971796LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORSK971791VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSIONK971802VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSIONK971797LAPAROSCOPIC BLADDER NECK SUSPENSION KITK971801LAPAROTOMY BLADDER NECK SUSPENSION KIT

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Related Devices (Code: HET)

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.

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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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