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FDA 510(k)

CLEANSING AGENT, NEW WOUND (DEBRISSU)

K-Number: K760469 · 1976-12-16

ApplicantPharmaseal Laboratories
Decision Date1976-12-16
Product CodeKOZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLEANSING AGENT, NEW WOUND (DEBRISSU) is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaseal Laboratories. It received FDA 510(k) clearance on 1976-12-16 under 510(k) number K760469. The device is classified under product code KOZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEANSING AGENT, NEW WOUND (DEBRISSU)?

CLEANSING AGENT, NEW WOUND (DEBRISSU) is a medical device that received FDA 510(k) clearance on 1976-12-16. The listed applicant is Pharmaseal Laboratories. The 510(k) number is K760469.

When did CLEANSING AGENT, NEW WOUND (DEBRISSU) receive FDA 510(k) clearance?

CLEANSING AGENT, NEW WOUND (DEBRISSU) received FDA 510(k) clearance on 1976-12-16, under 510(k) number K760469.

Who is the listed applicant for CLEANSING AGENT, NEW WOUND (DEBRISSU)?

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

What is the FDA product code for CLEANSING AGENT, NEW WOUND (DEBRISSU)?

The FDA product code for CLEANSING AGENT, NEW WOUND (DEBRISSU) is KOZ.

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.

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Other records listing Pharmaseal Laboratories 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.

K800737DEBRISAN (DEXTRANOMER) PASTEK801146SAMPLING KITK800874PELVIC EXAM TRAYK800362FLUID DISPENSING SYSTEM

Related Devices (Code: KOZ)

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.

K905206INCARE PINSITE DRESSINGHollister, Inc.K905688CUTINOVA HYDROBeiersdorf, Inc.K905069IODOSORB GELPerstorp AB C/O Robert Joel SlomoffK904604REDI-RELEASE ABSORBENT DRESSINGFountain Pharmaceuticals, Inc.K896828BIOCLUSIVE(R) ABSORBENT DRESSINGJohnson & Johnson InternationalK903645DERMASORB WOUND CONTACT LAYER DRESSINGConvatec, 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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