MediClear PreOp— 510(k) K163556
Substantially EquivalentCovalontechnologies, Inc.
FDA 510(k) clearance K163556 for MediClear PreOp, Substantially Equivalent on 2017-09-14. Applicant: Covalontechnologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Covalontechnologies, Inc.
- Product code
- Code KKX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississsauga, CA
Recent devices under product code KKX
view all- K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II
- K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
- K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial
- K200238 — ControlRad Sterile Cover
- K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX
More clearances from Covalontechnologies, Inc.
view all- K150550 — SilverCoat Silicone Foley Catheter
- K121819 — SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
- K112549 — IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
- K043296 — COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
- K050177 — COLACTIVE COLLAGEN WOUND DRESSING
Data sourced from openFDA. This site is unofficial and independent of the FDA.