GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE— 510(k) K954306
Substantially EquivalentGamp & Assoc.
FDA 510(k) clearance K954306 for GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE, Substantially Equivalent on 1995-12-22. Applicant: Gamp & Assoc.. Device class: 2.
Clearance details
- Applicant
- Gamp & Assoc.
- Product code
- Code HQB
- Device class
- Class 2
- Regulation
- 21 CFR 886.4690
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chesterfield, MO, US
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More clearances from Gamp & Assoc.
view all- K952569 — GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR
- K952581 — GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR
- K952585 — GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR
- K954307 — GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE
- K954308 — GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE
Adverse events under product code HQB
product code HQB- Other
- 2
- Total
- 2
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.