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)

NIGHTFORM

K-Number: K041996 · 2004-08-03

ApplicantPlastic Surgery Solutions, LLC
Decision Date2004-08-03
Product CodeFRP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NIGHTFORM is the device name listed in this FDA 510(k) record. The listed applicant is Plastic Surgery Solutions, LLC. It received FDA 510(k) clearance on 2004-08-03 under 510(k) number K041996. The device is classified under product code FRP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIGHTFORM?

NIGHTFORM is a medical device that received FDA 510(k) clearance on 2004-08-03. The listed applicant is Plastic Surgery Solutions, LLC. The 510(k) number is K041996.

When did NIGHTFORM receive FDA 510(k) clearance?

NIGHTFORM received FDA 510(k) clearance on 2004-08-03, under 510(k) number K041996.

Who is the listed applicant for NIGHTFORM?

The FDA 510(k) record lists Plastic Surgery Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIGHTFORM?

The FDA product code for NIGHTFORM is FRP.

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

Related Devices (Code: FRP)

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.

K082367INFANT SLEEP BEANIELife Innovations, LLCK090284RES-Q INFANT WEDGE AND SLINGCr Enterprises, LLCK062143KOZY COMFORT INFANT POSITIONERAlfred E Mann Inst. For Biomedical EngineeringK060986HEAD BEDSteven H. Warnock, M.D.K051300ROBIN HOOD VESTKamber CorporationK003511KENDALL-LTP TURNER SAVE-A-LINEThe Ludlow Company LP

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.

↑