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FDA 510(k)

HEAD-UP SUPINE SAFETY SUPPORT CUSHION

K-Number: K821306 · 1982-06-07

Decision Date1982-06-07
Product CodeEPW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEAD-UP SUPINE SAFETY SUPPORT CUSHION is the device name listed in this FDA 510(k) record. The listed applicant is Med-Life, Inc.. It received FDA 510(k) clearance on 1982-06-07 under 510(k) number K821306. The device is classified under product code EPW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEAD-UP SUPINE SAFETY SUPPORT CUSHION?

HEAD-UP SUPINE SAFETY SUPPORT CUSHION is a medical device that received FDA 510(k) clearance on 1982-06-07. The listed applicant is Med-Life, Inc.. The 510(k) number is K821306.

When did HEAD-UP SUPINE SAFETY SUPPORT CUSHION receive FDA 510(k) clearance?

HEAD-UP SUPINE SAFETY SUPPORT CUSHION received FDA 510(k) clearance on 1982-06-07, under 510(k) number K821306.

Who is the listed applicant for HEAD-UP SUPINE SAFETY SUPPORT CUSHION?

The FDA 510(k) record lists Med-Life, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEAD-UP SUPINE SAFETY SUPPORT CUSHION?

The FDA product code for HEAD-UP SUPINE SAFETY SUPPORT CUSHION is EPW.

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.

Other records listing Med-Life, 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.

Related Devices (Code: EPW)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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