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FDA 510(k)

O. B. PACK II

K-Number: K902272 · 1990-08-15

ApplicantCustomed, Inc.
Decision Date1990-08-15
Product CodeHHD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

O. B. PACK II is the device name listed in this FDA 510(k) record. The listed applicant is Customed, Inc.. It received FDA 510(k) clearance on 1990-08-15 under 510(k) number K902272. The device is classified under product code HHD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O. B. PACK II?

O. B. PACK II is a medical device that received FDA 510(k) clearance on 1990-08-15. The listed applicant is Customed, Inc.. The 510(k) number is K902272.

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

O. B. PACK II received FDA 510(k) clearance on 1990-08-15, under 510(k) number K902272.

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

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 II?

The FDA product code for O. B. PACK II is HHD.

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: HHD)

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.

K071827ALWAYS MENSTRUAL PADSProcter & Gamble, Inc.K012629ALWAYS DUETSProcter & Gamble Co.K003843ENVIVE MINIFORMSProcter & Gamble Co.K993870UNSCENTED INTERLABIAL MENSTRUAL PADProcter & Gamble Co.K980395GLADRAGS COTTON MENSTRUAL PADKeepers!, Inc.K953470FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)Mediquip, 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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