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FDA 510(k)

ALPINE REUSABLE LEG BAGS

K-Number: K934052 · 1994-01-07

ApplicantSierra Laboratories, Inc.
Decision Date1994-01-07
Product CodeFAQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALPINE REUSABLE LEG BAGS is the device name listed in this FDA 510(k) record. The listed applicant is Sierra Laboratories, Inc.. It received FDA 510(k) clearance on 1994-01-07 under 510(k) number K934052. The device is classified under product code FAQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPINE REUSABLE LEG BAGS?

ALPINE REUSABLE LEG BAGS is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is Sierra Laboratories, Inc.. The 510(k) number is K934052.

When did ALPINE REUSABLE LEG BAGS receive FDA 510(k) clearance?

ALPINE REUSABLE LEG BAGS received FDA 510(k) clearance on 1994-01-07, under 510(k) number K934052.

Who is the listed applicant for ALPINE REUSABLE LEG BAGS?

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

What is the FDA product code for ALPINE REUSABLE LEG BAGS?

The FDA product code for ALPINE REUSABLE LEG BAGS is FAQ.

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Other records listing Sierra Laboratories, Inc. as applicant

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Related Devices (Code: FAQ)

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.

K962604PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZINGConvatec, A Division of E.R. Squibb & SonsK960217CPR URINE BAGCustom Pack ReliabilityK955609CONVEEN URINE BAG - STERILEColoplast Corp.K953767PROSYS BEDSIDE DRAINAGE BAGConvatec, A Division of E.R. Squibb & SonsK953783CONVEEN LEG BAG STRAPColoplast Corp.K951945PROSYS LEG BAGConvatec, A Division of E.R. Squibb & Sons

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.

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