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FDA 510(k)

HYPERTONIC SALINE WET DRESSING - STERILE

K-Number: K941999 · 1994-06-29

ApplicantTrinity Laboratories, Inc.
Decision Date1994-06-29
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

HYPERTONIC SALINE WET DRESSING - STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Laboratories, Inc.. It received FDA 510(k) clearance on 1994-06-29 under 510(k) number K941999. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the HYPERTONIC SALINE WET DRESSING - STERILE?

HYPERTONIC SALINE WET DRESSING - STERILE is a medical device that received FDA 510(k) clearance on 1994-06-29. The listed applicant is Trinity Laboratories, Inc.. The 510(k) number is K941999.

When did HYPERTONIC SALINE WET DRESSING - STERILE receive FDA 510(k) clearance?

HYPERTONIC SALINE WET DRESSING - STERILE received FDA 510(k) clearance on 1994-06-29, under 510(k) number K941999.

Who is the listed applicant for HYPERTONIC SALINE WET DRESSING - STERILE?

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

What is the FDA product code for HYPERTONIC SALINE WET DRESSING - STERILE?

The FDA product code for HYPERTONIC SALINE WET DRESSING - STERILE is KMF.

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Other records listing Trinity 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.

K981441HEART CATH TRAY, STERILE, DISPOSABLEK974238DENTAL TRAY, STERILE, DISPOSABLEK974286CIRCUMCISION TRAY, CAT. NO. 70340K972160CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TESTK970722EYE TRAYK965201O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE

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Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, Inc.

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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