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FDA 510(k)

NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)

K-Number: K964231 · 1997-03-10

ApplicantNorth American Sterilization & Packaging Co.
Decision Date1997-03-10
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) is the device name listed in this FDA 510(k) record. The listed applicant is North American Sterilization & Packaging Co.. It received FDA 510(k) clearance on 1997-03-10 under 510(k) number K964231. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)?

NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) is a medical device that received FDA 510(k) clearance on 1997-03-10. The listed applicant is North American Sterilization & Packaging Co.. The 510(k) number is K964231.

When did NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) receive FDA 510(k) clearance?

NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) received FDA 510(k) clearance on 1997-03-10, under 510(k) number K964231.

Who is the listed applicant for NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)?

The FDA 510(k) record lists North American Sterilization & Packaging Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)?

The FDA product code for NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) is KMF.

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Other records listing North American Sterilization & Packaging Co. 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.

K963753NASP TRANSPARENT DRESSINGK962352HYDROGEL SKIN DRESSINGK925588NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRIK925593NORTEC STERILE WATER FOR DEVICE IRRIGATIONK925161NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIOK911865NORTEC CONNECTING TUBE SET

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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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