CUSTOM ENT PACKS— 510(k) K935621

Substantially Equivalent

Associated Medical

FDA 510(k) clearance K935621 for CUSTOM ENT PACKS, Substantially Equivalent on 1994-03-30. Applicant: Associated Medical. Device class: 1.

Clearance details

Applicant: Associated Medical
Product code: Code LRP
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1993-11-22
Decision date: 1994-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRP

K963723 — LACERATION TRAY1996-11-27
K951811 — OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK1995-05-31
K940239 — EYE TRAY1994-06-28
K940646 — ORTHOPEDIC TRAY PRODUCT LINE1994-03-11
K940444 — GENERAL SURGERY TRAY1994-03-07

More clearances from Associated Medical

K936255 — CUSTOM CV PACK1994-03-31
K935622 — CUSTOM PLASTIC PACKS1994-02-07

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