GILLETTE SABRE SYRINGE— 510(k) K833655
Substantially EquivalentIntermedics, Inc.
FDA 510(k) clearance K833655 for GILLETTE SABRE SYRINGE, Substantially Equivalent on 1983-12-29. Applicant: Intermedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Intermedics, Inc.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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More clearances from Intermedics, Inc.
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- K962174 — BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
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- K960281 — IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY
Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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.