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FDA 510(k)

DECALCIFYING SOLUTION II

K-Number: K881359 · 1988-04-19

ApplicantStephens Scientific
Decision Date1988-04-19
Product CodeKOX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DECALCIFYING SOLUTION II is the device name listed in this FDA 510(k) record. The listed applicant is Stephens Scientific. It received FDA 510(k) clearance on 1988-04-19 under 510(k) number K881359. The device is classified under product code KOX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DECALCIFYING SOLUTION II?

DECALCIFYING SOLUTION II is a medical device that received FDA 510(k) clearance on 1988-04-19. The listed applicant is Stephens Scientific. The 510(k) number is K881359.

When did DECALCIFYING SOLUTION II receive FDA 510(k) clearance?

DECALCIFYING SOLUTION II received FDA 510(k) clearance on 1988-04-19, under 510(k) number K881359.

Who is the listed applicant for DECALCIFYING SOLUTION II?

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

What is the FDA product code for DECALCIFYING SOLUTION II?

The FDA product code for DECALCIFYING SOLUTION II is KOX.

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 Stephens Scientific 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.

K893772TISSUE EMBEDDING MEDIUMK872625DECALCIFYING SOLUTIONK832011AMERI CLEAR

Related Devices (Code: KOX)

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.

K934790SEPP ADHESIVE REMOVERMedi-Flex Hospital Products, Inc.K931933CHAD LABS ADHESIVE BANDAGE REMOVERChad Labs Corp.K924976ALLKARE(TM) ADHESIVE REMOVER WIPEConvatec, A Division of E.R. Squibb & SonsK924571MEDI-SOLOrange-Sol, Inc.K9256183M REMOVER LOTION PRODUCT NUMBER 86XX3M Health Care, Ltd.K923351SKIN SUPPORT PREP PADColoplast Corp.

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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