SPENCO BREAST FORMS— 510(k) K896533

Substantially Equivalent

Spenco Medical Corp.

FDA 510(k) clearance K896533 for SPENCO BREAST FORMS, Substantially Equivalent on 1989-12-13. Applicant: Spenco Medical Corp.. Device class: 1.

Clearance details

Applicant: Spenco Medical Corp.
Product code: Code KCZ
Device class: Class 1
Regulation: 21 CFR 878.3800
Advisory panel: General, Plastic Surgery
Date received: 1989-11-14
Decision date: 1989-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waco, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCZ

K990458 — STRAUMANN EXTRAORAL IMPLANT SYSTEM1999-04-16
K951324 — MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS1995-05-26
K933465 — COSMET1994-07-20
K932978 — CALSSIQUE OR MYSTIQUE1993-12-22
K932899 — CLASSIQUE1993-12-16

More clearances from Spenco Medical Corp.

K981902 — SPENCO SILICONE GEL SHEET1998-06-25
K922228 — 2ND SKIN STERILE ADHESIVE STRIP1992-12-11
K911550 — 2ND SKIN MOIST BURN PADS WITH ALOE1991-09-06
K910927 — SPENCIO SKIN GUARD KIT1991-06-03
K894898 — 2ND SKIN NON-STICK MOIST BURN PADS1989-08-23

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