SEA-BOND ADHEVISE DENTURE CUSHIONS— 510(k) K770175

Substantially Equivalent

Combe, Inc.

FDA 510(k) clearance K770175 for SEA-BOND ADHEVISE DENTURE CUSHIONS, Substantially Equivalent on 1977-02-04. Applicant: Combe, Inc.. Device class: 2.

Clearance details

Applicant: Combe, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1977-01-26
Decision date: 1977-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II2023-10-25
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)2023-05-18
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial2021-07-30
K200238 — ControlRad Sterile Cover2020-04-26
K163556 — MediClear PreOp2017-09-14

More clearances from Combe, Inc.

K942203 — OTC DENTURE CLEANSER1994-08-10
K925259 — CFR MONOGRAPH1993-01-11
K863375 — SEA-BOND1986-09-19
K780719 — FUNGUS FIGHTER INSOLES1978-10-10
K770413 — CUSHIONS, DENTURE ADHESIVE, ALL-DAY1977-06-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.