Scanlan Atraum Instrument Jaw Cover
FDA 510(k) K841513 · Scanlan Intl., Inc.
510(k) numberK841513
Submission
- Device name
- Scanlan Atraum Instrument Jaw Cover
- Applicant
- Scanlan Intl., Inc.
Mchenry, IL, US - Received
- April 12, 1984
- Decision date
- July 6, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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| K851825 | Scanlan Tunneler, Sheath & TipDWS · Traditional | 07/12/1985SE |
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| K841085 | Scanlan Colormark Skin MarkerFZZ · Traditional | 06/11/1984SE |
| K841515 | Scanlan Vascu-Statt IIHRG · Traditional | 06/05/1984SE |
| K841514 | Scanlan Vascu-Statt II ApproximatorHRQ · Traditional | 06/05/1984SE |
Questions and answers
When was Scanlan Atraum Instrument Jaw Cover cleared by the FDA?
Scanlan Atraum Instrument Jaw Cover (K841513) received a 510(k) decision of Substantially Equivalent on July 6, 1984, 85 days after the submission was received.