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FDA 510(k)

HEAD RETAINING DEVICE

K-Number: K961467 · 1996-08-09

ApplicantS. and H. Engineering, Inc.
Decision Date1996-08-09
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HEAD RETAINING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is S. and H. Engineering, Inc.. It received FDA 510(k) clearance on 1996-08-09 under 510(k) number K961467. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEAD RETAINING DEVICE?

HEAD RETAINING DEVICE is a medical device that received FDA 510(k) clearance on 1996-08-09. The listed applicant is S. and H. Engineering, Inc.. The 510(k) number is K961467.

When did HEAD RETAINING DEVICE receive FDA 510(k) clearance?

HEAD RETAINING DEVICE received FDA 510(k) clearance on 1996-08-09, under 510(k) number K961467.

Who is the listed applicant for HEAD RETAINING DEVICE?

The FDA 510(k) record lists S. and H. Engineering, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEAD RETAINING DEVICE?

The FDA product code for HEAD RETAINING DEVICE is IYE.

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 S. and H. Engineering, 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.

K962487BREAST TREATMENT AID M200K961170BREAST TREATMENT AIDK9225646 FRENCH CATHETER

Related Devices (Code: IYE)

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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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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