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FDA 510(k)

PREP TRAY, PREOPERATIVE SKIN

K-Number: K781797 · 1978-11-08

ApplicantPharmaseal Div., Baxter Healthcare Corp.
Decision Date1978-11-08
Product CodeOJU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PREP TRAY, PREOPERATIVE SKIN is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaseal Div., Baxter Healthcare Corp.. It received FDA 510(k) clearance on 1978-11-08 under 510(k) number K781797. The device is classified under product code OJU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREP TRAY, PREOPERATIVE SKIN?

PREP TRAY, PREOPERATIVE SKIN is a medical device that received FDA 510(k) clearance on 1978-11-08. The listed applicant is Pharmaseal Div., Baxter Healthcare Corp.. The 510(k) number is K781797.

When did PREP TRAY, PREOPERATIVE SKIN receive FDA 510(k) clearance?

PREP TRAY, PREOPERATIVE SKIN received FDA 510(k) clearance on 1978-11-08, under 510(k) number K781797.

Who is the listed applicant for PREP TRAY, PREOPERATIVE SKIN?

The FDA 510(k) record lists Pharmaseal Div., Baxter Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREP TRAY, PREOPERATIVE SKIN?

The FDA product code for PREP TRAY, PREOPERATIVE SKIN is OJU.

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Other records listing Pharmaseal Div., Baxter Healthcare Corp. 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.

K792369HYPERALIMENTATION DRESSING TRAYK792141CONTINUOUS FLUSH DEVICEK792019PHADECODE XA INHIBITOR ASSAYK791773VENTILATOR TUBE WITH FILTERK791156AMIPAQUE MYELOGRAM TRAYK790896TWO-WAY ANESTHESIA FILTER

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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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