FDA 510(k)

AMPU-PAK

K-Number: K860511 · 1986-08-04

ApplicantAmmerman Medical Enterprises, Inc.

Decision Date1986-08-04

Product CodeLPZ

DecisionSubstantially Equivalent

Device Summary

AMPU-PAK is the device name listed in this FDA 510(k) record. The listed applicant is Ammerman Medical Enterprises, Inc.. It received FDA 510(k) clearance on 1986-08-04 under 510(k) number K860511. The device is classified under product code LPZ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMPU-PAK?

AMPU-PAK is a medical device that received FDA 510(k) clearance on 1986-08-04. The listed applicant is Ammerman Medical Enterprises, Inc.. The 510(k) number is K860511.

When did AMPU-PAK receive FDA 510(k) clearance?

AMPU-PAK received FDA 510(k) clearance on 1986-08-04, under 510(k) number K860511.

Who is the listed applicant for AMPU-PAK?

The FDA 510(k) record lists Ammerman Medical Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMPU-PAK?

The FDA product code for AMPU-PAK is LPZ.

Related Devices (Code: LPZ)

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.

K021702CRYOBAG, MODEL CBOrigen Biomedical, Inc.K915471CRYOBAGJanus Biomedical, Inc.K863872TAMPER HAMPERHydro-Med Products, Inc.K861761ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGETravenol Laboratories, S.A.K853663ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STORTravenol Laboratories, S.A.

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.