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FDA 510(k)

SADDLEBAG INSTRUMENT PAD W/POUCHES

K-Number: K821395 · 1982-06-03

ApplicantKleen Test Products
Decision Date1982-06-03
Product Code
DecisionSubstantially Equivalent

Device Summary

SADDLEBAG INSTRUMENT PAD W/POUCHES is the device name listed in this FDA 510(k) record. The listed applicant is Kleen Test Products. It received FDA 510(k) clearance on 1982-06-03 under 510(k) number K821395. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SADDLEBAG INSTRUMENT PAD W/POUCHES?

SADDLEBAG INSTRUMENT PAD W/POUCHES is a medical device that received FDA 510(k) clearance on 1982-06-03. The listed applicant is Kleen Test Products. The 510(k) number is K821395.

When did SADDLEBAG INSTRUMENT PAD W/POUCHES receive FDA 510(k) clearance?

SADDLEBAG INSTRUMENT PAD W/POUCHES received FDA 510(k) clearance on 1982-06-03, under 510(k) number K821395.

Who is the listed applicant for SADDLEBAG INSTRUMENT PAD W/POUCHES?

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

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 Kleen Test Products 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.

K890039KLEEN TEST BASIN SETK890539SURE COUNT LIGHT HANDLE COVERK890098KLEEN TEST O.R. KITK853622SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030K853454SURE COUNT 5 & 10 SPONGE COUNTERK853315CAUTERY TIP CLEANING PAD

View all 17 devices →

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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