CPR C-SECTION DELIVERY PACK— 510(k) K960243

Name: FDA 510(k) clearance K960243
Creator: U.S. Food and Drug Administration
Published: 1996-05-23

Substantially Equivalent

Custom Pack Reliability

FDA 510(k) clearance K960243 for CPR C-SECTION DELIVERY PACK, Substantially Equivalent on 1996-05-23. Applicant: Custom Pack Reliability. Device class: 2.

Clearance details

Applicant: Custom Pack Reliability
Product code: Code MLS
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1996-01-16
Decision date: 1996-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MLS

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K961993 — BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)1996-07-03
K940518 — C-SECTION TRAY1994-08-18
K932216 — C-SECTION, LABOR & DELIVERY TRAYS (PACKS)1994-04-19
K936120 — LABOR AND DELIVERY TRAY1994-03-30
K931722 — CARAPACE LABOR AND DELIVERY SETS1994-03-23

More clearances from Custom Pack Reliability

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K960205 — CPR TRACHEOTOMY CARE TRAY1996-08-27
K960239 — CPR D & C TRAY1996-05-23
K960216 — CPR SUCTION CATHETER KIT1996-04-15
K960206 — CPR DRESSING CHANGE TRAY1996-04-12
K960210 — CPR ORTHO HAND PACK1996-04-12

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