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)

COMBINE II WETPROOF PAD

K-Number: K923116 · 1992-10-06

ApplicantHermitage Hospital Products, Inc.
Decision Date1992-10-06
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COMBINE II WETPROOF PAD is the device name listed in this FDA 510(k) record. The listed applicant is Hermitage Hospital Products, Inc.. It received FDA 510(k) clearance on 1992-10-06 under 510(k) number K923116. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBINE II WETPROOF PAD?

COMBINE II WETPROOF PAD is a medical device that received FDA 510(k) clearance on 1992-10-06. The listed applicant is Hermitage Hospital Products, Inc.. The 510(k) number is K923116.

When did COMBINE II WETPROOF PAD receive FDA 510(k) clearance?

COMBINE II WETPROOF PAD received FDA 510(k) clearance on 1992-10-06, under 510(k) number K923116.

Who is the listed applicant for COMBINE II WETPROOF PAD?

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

What is the FDA product code for COMBINE II WETPROOF PAD?

The FDA product code for COMBINE II WETPROOF PAD is NAB.

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 Hermitage Hospital Products, 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.

K941802OR TOWELK923115CLINISORBK891324HERMITEX SPONGEK863737SPONGES STERILE TWIN PAKT AND SINGLESK843788CUSTOM BURN DRESSING KITK822987DRESSING SPONGE

View all 8 devices →

Related Devices (Code: NAB)

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.

K946015IVALON EXTERNAL SPONGEIvalonK940755ISOLYER (4X4, 8PLY)Isolyer Co.K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle Medical, 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.

↑