Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DEY-PAK PURIFIED WATER, USP, STERILE

K-Number: K875011 · 1988-01-22

ApplicantDey Laboratories, Inc.
Decision Date1988-01-22
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEY-PAK PURIFIED WATER, USP, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Dey Laboratories, Inc.. It received FDA 510(k) clearance on 1988-01-22 under 510(k) number K875011. The device is classified under product code CCQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEY-PAK PURIFIED WATER, USP, STERILE?

DEY-PAK PURIFIED WATER, USP, STERILE is a medical device that received FDA 510(k) clearance on 1988-01-22. The listed applicant is Dey Laboratories, Inc.. The 510(k) number is K875011.

When did DEY-PAK PURIFIED WATER, USP, STERILE receive FDA 510(k) clearance?

DEY-PAK PURIFIED WATER, USP, STERILE received FDA 510(k) clearance on 1988-01-22, under 510(k) number K875011.

Who is the listed applicant for DEY-PAK PURIFIED WATER, USP, STERILE?

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

What is the FDA product code for DEY-PAK PURIFIED WATER, USP, STERILE?

The FDA product code for DEY-PAK PURIFIED WATER, USP, STERILE is CCQ.

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 Dey 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.

K972778DEY VIAL SODIUM CHLORIDE 3%K910239NEBU-SOL METERED DOSE DISPENSER (TM)K880411DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILEK875024DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USPK831532OCULAR IRRIGATING CANNULA

Related Devices (Code: CCQ)

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.

K972397EZ SPRAYIntertex Research, Inc.K964956E-Z SPACER MASK (SMALL)Airpharma, LLCK961894MDI TUTORMdi Tutor, Inc.K961455MEDSHIELD/AEROCHAMBERDiemolding Corp.K960593SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100Aradigm Corp.K922033SALINE SOLUTION- STERILETrinity Laboratories, 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.

↑