Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FOAM CARE ONE STEP PREP

K-Number: K843636 · 1984-11-16

ApplicantBallard Medical Products
Decision Date1984-11-16
Product CodeGEC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FOAM CARE ONE STEP PREP is the device name listed in this FDA 510(k) record. The listed applicant is Ballard Medical Products. It received FDA 510(k) clearance on 1984-11-16 under 510(k) number K843636. The device is classified under product code GEC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOAM CARE ONE STEP PREP?

FOAM CARE ONE STEP PREP is a medical device that received FDA 510(k) clearance on 1984-11-16. The listed applicant is Ballard Medical Products. The 510(k) number is K843636.

When did FOAM CARE ONE STEP PREP receive FDA 510(k) clearance?

FOAM CARE ONE STEP PREP received FDA 510(k) clearance on 1984-11-16, under 510(k) number K843636.

Who is the listed applicant for FOAM CARE ONE STEP PREP?

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

What is the FDA product code for FOAM CARE ONE STEP PREP?

The FDA product code for FOAM CARE ONE STEP PREP is GEC.

Other records listing Ballard Medical Products 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.

K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEK022398REUSABLE BRONCHIAL BIOPSY FORCEPSK013892LUTZ NEEDLEK000495BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLESK993138BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KITK990376BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME

View all 26 devices →

Related Devices (Code: GEC)

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.

K971473IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCKM-Pact Worldwide Management Corp.K960621EXPANDACELL INSTRUMENT WIPEShippert Medical Technologies Corp.K900691BIODYNE INSTRUMENT WIPESBio-Dyne, Inc.K896085SURGI-BRUSHSparta Surgical Corp.K875033STERILE SCRUBBY SCRUB BRUSHMedsurg Industries, Inc.K875129STERI-CLENSAbsorbent Cotton Co., 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.

↑