OPPORTUNITY SUTURE REMOVAL KIT— 510(k) K971095

Name: FDA 510(k) clearance K971095
Creator: U.S. Food and Drug Administration
Published: 1997-09-16

Substantially Equivalent for Some Indications

Opportunity, Inc.

FDA 510(k) clearance K971095 for OPPORTUNITY SUTURE REMOVAL KIT, Substantially Equivalent for Some Indications on 1997-09-16. Applicant: Opportunity, Inc.. Device class: Unclassified.

Clearance details

Applicant: Opportunity, Inc.
Product code: Code EFQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1997-03-24
Decision date: 1997-09-16
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Highland Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFQ

view all

K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE1999-08-12
K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S1999-06-11
K990974 — VITOP DRESSING1999-06-09
K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE1999-04-23
K984187 — CROSSTEX NON-WOVEN SPONGES1999-02-18

More clearances from Opportunity, Inc.

view all

K971088 — OPPORTUNITY INCISION AND DRAINAGE TRAY1997-09-16
K971089 — OPPORTUNITY, INC. LACERATION TRAY1997-09-16
K971090 — OPPORTUNITY DRESSING CHANGE TRAY1997-09-16
K971091 — OPPURTUNITY TRACHEOSTOMY CARE KIT1997-09-16
K971093 — OPPORTUNITY I.V. START KIT1997-09-16

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