ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE— 510(k) K954718
Substantially EquivalentEllman Intl., Inc.
FDA 510(k) clearance K954718 for ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE, Substantially Equivalent on 1996-02-29. Applicant: Ellman Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Ellman Intl., Inc.
- Product code
- Code HEE
- Device class
- Class 2
- Regulation
- 21 CFR 884.5100
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sound Beach, NY, US
Recent devices under product code HEE
view all- K052365 — CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
- K021224 — ENDOCERVICAL BLOCK NEEDLE
- K000117 — AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
- K983897 — CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G
- K980238 — GYNEX EXTENDED REACH NEEDLE
More clearances from Ellman Intl., Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.