WILEY/ESPOSITO DENTAL GUARD— 510(k) K935713

Substantially Equivalent

Fvtnks

FDA 510(k) clearance K935713 for WILEY/ESPOSITO DENTAL GUARD, Substantially Equivalent on 1994-01-05. Applicant: Fvtnks. Device class: 1.

Clearance details

Applicant: Fvtnks
Product code: Code BRW
Device class: Class 1
Regulation: 21 CFR 868.5820
Advisory panel: Anesthesiology
Date received: 1993-11-30
Decision date: 1994-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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Recent devices under product code BRW

K945727 — CATCO NEONATAL PALATE GUARD1994-12-07
K851640 — TIP TOLEDO INCISOR PROTECTOR1985-09-18

More clearances from Fvtnks

K945482 — DISPOSABLE, CPAP OXYGEN MASK1995-09-19
K945440 — DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK1994-11-08
K940544 — DOUBLE TRACH SEIVEL CONNECTOR1994-04-19

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