FIBER OPTIC LIGHT GUIDE #60-0767
FDA 510(k) clearance K802773 · decided 1980-12-16
Clearance details
- K-number
- K802773
- Device name
- FIBER OPTIC LIGHT GUIDE #60-0767
- Applicant
- Aspen Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-03
- Decision date
- 1980-12-16
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- EQH
- Device class
- 1
- Regulation number
- 874.4350
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (K945876) | Wells Johnson Co. | 1995-12-04 |
| JED-LIGHT FIBEROPTIC LIGHT SOURCE (K954184) | Jedmed Instrument Co. | 1995-11-13 |
| COLD LIGHT SOURCE LOS 150 (K951829) | Laser-Optik-Systeme GmbH & Co. KG | 1995-07-10 |
| BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (K932771) | Xomed-Treace, Inc. | 1994-08-24 |
| GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (K941661) | Gm Engineering, Inc. | 1994-08-23 |
| GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (K941662) | Gm Engineering, Inc. | 1994-07-20 |
| SAPHIRE PLUS SURGICAL MIRROR (K934911) | San Diego Swiss Machining, Inc. | 1994-06-21 |
| MID LABS TWIN ILLUMINATOR (K932131) | Medical Instrument Development Laboratories, Inc. | 1994-04-01 |
| ASPIRATING ENDO OCULAR PROBE (K930123) | Surgical Technologies, Inc. | 1994-02-16 |
| FIBEROPTIC LIGHTSOURCES AND CARRIERS (K933145) | Electro Fiberoptics Corp. | 1993-09-07 |
| THROAT-A-SCOPE (K923227) | Truphatek, Ltd. | 1992-12-04 |
| DISPOSABLE ENDOILLUMINATOR (K923774) | O.R. Specialties, Inc. | 1992-10-19 |
Recalls involving this device
No recalls on record reference this clearance.