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FDA 510(k)

DEEP CONVEX FACE PLATE

K-Number: K820493 · 1982-03-10

ApplicantSmith'S Ostomy Products, Inc.
Decision Date1982-03-10
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEEP CONVEX FACE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Smith'S Ostomy Products, Inc.. It received FDA 510(k) clearance on 1982-03-10 under 510(k) number K820493. 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 DEEP CONVEX FACE PLATE?

DEEP CONVEX FACE PLATE is a medical device that received FDA 510(k) clearance on 1982-03-10. The listed applicant is Smith'S Ostomy Products, Inc.. The 510(k) number is K820493.

When did DEEP CONVEX FACE PLATE receive FDA 510(k) clearance?

DEEP CONVEX FACE PLATE received FDA 510(k) clearance on 1982-03-10, under 510(k) number K820493.

Who is the listed applicant for DEEP CONVEX FACE PLATE?

The FDA 510(k) record lists Smith'S Ostomy Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEEP CONVEX FACE PLATE?

The FDA product code for DEEP CONVEX FACE PLATE 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.

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Other records listing Smith'S Ostomy 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.

K802424OSTOMATE THIRD HAND

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.

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