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FDA 510(k)

BIO-DERM COUPLING LOTION

K-Number: K827885 · 1982-01-29

ApplicantWhs Products, Inc.
Decision Date1982-01-29
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BIO-DERM COUPLING LOTION is the device name listed in this FDA 510(k) record. The listed applicant is Whs Products, Inc.. It received FDA 510(k) clearance on 1982-01-29 under 510(k) number K827885. The device is classified under product code HGL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-DERM COUPLING LOTION?

BIO-DERM COUPLING LOTION is a medical device that received FDA 510(k) clearance on 1982-01-29. The listed applicant is Whs Products, Inc.. The 510(k) number is K827885.

When did BIO-DERM COUPLING LOTION receive FDA 510(k) clearance?

BIO-DERM COUPLING LOTION received FDA 510(k) clearance on 1982-01-29, under 510(k) number K827885.

Who is the listed applicant for BIO-DERM COUPLING LOTION?

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

What is the FDA product code for BIO-DERM COUPLING LOTION?

The FDA product code for BIO-DERM COUPLING LOTION is HGL.

Related Clinical Trials

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.

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Other records listing Whs Products, 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.

K834088GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLINGK833172ECG-GEL ELECTRODE GELK828673RICH-MAR ULTRASOUND COUPLING LOTION

Related Devices (Code: HGL)

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.

K952031ULTRASOUND TRANSDUCER, MODEL US917Advanced Medical Systems, Inc.K923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONAdvanced Medical Systems, Inc.K924516OP3/VP4Huntleigh Technology, Inc.K903348ULTRASONIC PULSED DOPPLER IMAGING SYSTEMAdvanced Technology Laboratories, Inc.K900966EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBEHitachi Medical Corp. of AmericaK901142MER MULTIPLANE VAGINAL PROBE (MVP)Medical Equipment Resources

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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