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FDA 510(k)

ACRO PACK

K-Number: K822121 · 1982-08-05

ApplicantGelman Sciences, Inc.
Decision Date1982-08-05
Product CodeJRL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACRO PACK is the device name listed in this FDA 510(k) record. The listed applicant is Gelman Sciences, Inc.. It received FDA 510(k) clearance on 1982-08-05 under 510(k) number K822121. The device is classified under product code JRL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACRO PACK?

ACRO PACK is a medical device that received FDA 510(k) clearance on 1982-08-05. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K822121.

When did ACRO PACK receive FDA 510(k) clearance?

ACRO PACK received FDA 510(k) clearance on 1982-08-05, under 510(k) number K822121.

Who is the listed applicant for ACRO PACK?

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

What is the FDA product code for ACRO PACK?

The FDA product code for ACRO PACK is JRL.

Other records listing Gelman Sciences, 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.

K946190DRUG DISPENSING SPIKEK943127PHARMASSURE LARGE VOLUME TRANSFER FILTERSK941589SYRINGE FILTER DEVICESK941020DRUG RECONSTITUTION FILTER DEVICEK942275VIAL VENT FILTERK941032UNKNOWN

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Related Devices (Code: JRL)

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.

K820455CENTRIFREE MICROPARTITION SYSTEMAmicon, Inc.K820224EMIT FREELEVEL SYSTEM ISyva Co.K812750IL 703, STAT SEPARATORInstrumentation Laboratory COK813159VACUSHIELD TMGelman Sciences, Inc.K810829ACRODISCGelman Sciences, Inc.K801500ULTRAFREE CALCIUM FILTERMillipore 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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