KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662— 510(k) K070685
Substantially EquivalentTyco Healthcare
FDA 510(k) clearance K070685 for KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662, Substantially Equivalent on 2007-09-14. Applicant: Tyco Healthcare. Device class: Unclassified.
Clearance details
- Applicant
- Tyco Healthcare
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Recent devices under product code FRO
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view all- K071049 — DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
- K070653 — KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662
- K061492 — MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
- K042709 — DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
- K040897 — DOVER ROB-NEL CATHETER
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.