O. B. PACK IV— 510(k) K902032
Substantially EquivalentCustomed, Inc.
FDA 510(k) clearance K902032 for O. B. PACK IV, Substantially Equivalent on 1990-09-28. Applicant: Customed, Inc.. Device class: 2.
Clearance details
- Applicant
- Customed, Inc.
- Product code
- Code HFC
- Device class
- Class 2
- Regulation
- 21 CFR 884.1050
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fajardo, PR, US
Recent devices under product code HFC
view allMore clearances from Customed, Inc.
view all- K974647 — FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
- K971920 — GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
- K964011 — SUCTION CATHETER TRAY PRODUCT NO. 900277
- K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
- K962596 — CUSTOMED BLOOD EXTRACTION KIT
Recalls naming K902032
K-number listed on FDA's recall record- Z-1419-2016 — Catalog Number: 9001297 PREMIUM OBSTETRICAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-2605-2015 — CESAREAN PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K902032.
Data sourced from openFDA. This site is unofficial and independent of the FDA.