STERILE SALINE SOLUTION— 510(k) K854155

Substantially Equivalent

I M, Inc.

FDA 510(k) clearance K854155 for STERILE SALINE SOLUTION, Substantially Equivalent on 1985-12-10. Applicant: I M, Inc.. Device class: 1.

Clearance details

Applicant: I M, Inc.
Product code: Code KMJ
Device class: Class 1
Regulation: 21 CFR 880.6375
Advisory panel: General Hospital
Date received: 1985-10-11
Decision date: 1985-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMJ

K142473 — Lubricating Jelly2015-04-13
K141028 — COLONGLIDE LUBRICANT2014-07-24
K131617 — COLONGLIDE(R) LUBRICANT2013-10-03
K121390 — LUBE JELLY SURINGE2012-08-10
K113689 — DUKAL LUBRICATING JELLY2012-05-04

More clearances from I M, Inc.

K914600 — NEUROLOGICAL SPONGE1992-12-30
K892389 — BIOPSY KIT1989-07-17
K881363 — SYRINGE PREFILLED WITH WATER1988-06-23
K880753 — UMBILICAL CORD CLAMP1988-04-27
K872741 — NUTRIPUMP1987-10-20

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