← Product Code [HQR](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR) · K952569

# GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR (K952569)

_Gamp & Assoc. · HQR · Jan 5, 1996 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR/K952569

## Device Facts

- **Applicant:** Gamp & Assoc.
- **Product Code:** [HQR](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR.md)
- **Decision Date:** Jan 5, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4100
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR/K952569](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQR/K952569)

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