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)

STOMAHESIVE STERILE WAFER

K-Number: K800750 · 1980-05-08

ApplicantSquibb & Sons, Inc.
Decision Date1980-05-08
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STOMAHESIVE STERILE WAFER is the device name listed in this FDA 510(k) record. The listed applicant is Squibb & Sons, Inc.. It received FDA 510(k) clearance on 1980-05-08 under 510(k) number K800750. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOMAHESIVE STERILE WAFER?

STOMAHESIVE STERILE WAFER is a medical device that received FDA 510(k) clearance on 1980-05-08. The listed applicant is Squibb & Sons, Inc.. The 510(k) number is K800750.

When did STOMAHESIVE STERILE WAFER receive FDA 510(k) clearance?

STOMAHESIVE STERILE WAFER received FDA 510(k) clearance on 1980-05-08, under 510(k) number K800750.

Who is the listed applicant for STOMAHESIVE STERILE WAFER?

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

What is the FDA product code for STOMAHESIVE STERILE WAFER?

The FDA product code for STOMAHESIVE STERILE WAFER is EXB.

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 Squibb & Sons, 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.

K821174TSH-SQUIBB RADIOIMMUNOASSAY KITK801424ESTRIOL RIA KIT FOR USE WITH GAMMAFLOK770726RIA KIT, T4 CLASPK761267ANGIOTENSIN I IMMUTOPE KIT

Related Devices (Code: EXB)

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.

K252140Heylo™ SystemColoplast Corp.K181643SmartBag (SmartPouch)11 Health Technologies LimitedK922730LAKE OSTOMY CARE SETLake Medical Products, Inc.K882878ODOR-END EMERGENCY CLEAN UP POWDERCdc Products Corp.K881636CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)Coloplast A/SK880306EMERGENCY-CLEAN UP(TM) ECPCdc Products Corp.

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.

↑