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FDA 510(k)

DEBRISAN (DEXTRANOMER) PASTE

K-Number: K800737 · 1980-08-04

ApplicantPharmaseal Laboratories
Decision Date1980-08-04
Product CodeKOZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEBRISAN (DEXTRANOMER) PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaseal Laboratories. It received FDA 510(k) clearance on 1980-08-04 under 510(k) number K800737. 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 DEBRISAN (DEXTRANOMER) PASTE?

DEBRISAN (DEXTRANOMER) PASTE is a medical device that received FDA 510(k) clearance on 1980-08-04. The listed applicant is Pharmaseal Laboratories. The 510(k) number is K800737.

When did DEBRISAN (DEXTRANOMER) PASTE receive FDA 510(k) clearance?

DEBRISAN (DEXTRANOMER) PASTE received FDA 510(k) clearance on 1980-08-04, under 510(k) number K800737.

Who is the listed applicant for DEBRISAN (DEXTRANOMER) PASTE?

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 DEBRISAN (DEXTRANOMER) PASTE?

The FDA product code for DEBRISAN (DEXTRANOMER) PASTE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K801146SAMPLING KITK800874PELVIC EXAM TRAYK800362FLUID DISPENSING SYSTEMK760469CLEANSING AGENT, NEW WOUND (DEBRISSU)

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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