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FDA 510(k)

O. B. PACK IV

K-Number: K902032 · 1990-09-28

ApplicantCustomed, Inc.
Decision Date1990-09-28
Product CodeHFC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

O. B. PACK IV is the device name listed in this FDA 510(k) record. The listed applicant is Customed, Inc.. It received FDA 510(k) clearance on 1990-09-28 under 510(k) number K902032. 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 O. B. PACK IV?

O. B. PACK IV is a medical device that received FDA 510(k) clearance on 1990-09-28. The listed applicant is Customed, Inc.. The 510(k) number is K902032.

When did O. B. PACK IV receive FDA 510(k) clearance?

O. B. PACK IV received FDA 510(k) clearance on 1990-09-28, under 510(k) number K902032.

Who is the listed applicant for O. B. PACK IV?

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

What is the FDA product code for O. B. PACK IV?

The FDA product code for O. B. PACK IV is HFC.

Other records listing Customed, 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.

K974647FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633K971920GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)K964011SUCTION CATHETER TRAY PRODUCT NO. 900277K962652URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)K962596CUSTOMED BLOOD EXTRACTION KITK961442UNIVERSAL DRAINAGE TRAY

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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.K902954OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)Permobil AB

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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