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FDA 510(k)

DC PACK TM

K-Number: K821134 · 1982-06-22

ApplicantSeamless Hospital Products Co.
Decision Date1982-06-22
Product CodeHFC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DC PACK TM is the device name listed in this FDA 510(k) record. The listed applicant is Seamless Hospital Products Co.. It received FDA 510(k) clearance on 1982-06-22 under 510(k) number K821134. The device is classified under product code HFC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DC PACK TM?

DC PACK TM is a medical device that received FDA 510(k) clearance on 1982-06-22. The listed applicant is Seamless Hospital Products Co.. The 510(k) number is K821134.

When did DC PACK TM receive FDA 510(k) clearance?

DC PACK TM received FDA 510(k) clearance on 1982-06-22, under 510(k) number K821134.

Who is the listed applicant for DC PACK TM?

The FDA 510(k) record lists Seamless Hospital Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DC PACK TM?

The FDA product code for DC PACK TM is HFC.

Other records listing Seamless Hospital Products Co. 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.

K841769INTERMITTENT URETHRAL CATHETER TRAYK823061BRUSH, SCRUB, OPERATING ROOMK820490IV START TRAYK781127CONNECTING TUBE, CONDUCTIVE, SURG.

Related Devices (Code: HFC)

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.

K974032ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATORA & A Medical, Inc.K960263CERVICAL MUCOUS ASPIRATION CATHETERCook Urological, Inc.K954903PEDI VAGINAL ASPIRATORCook Urological, Inc.K954102SELECTMUCUSSelect Medical Systems, Inc.K902242ENDOCERVICAL ASPIRATORInnovative Medical Products, Inc.K902032O. B. PACK IVCustomed, Inc.

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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