FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL
K Number: K822711
·
Decision Nov 3, 1982
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
1
Applicant Total
30
Review Days
57
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL
- K Number
- K822711
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Parker Laboratories, Inc.
- Date Received
- September 7, 1982
- Decision Date
- November 3, 1982
- Product Code
- FAX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FAX | Bougie, Urological | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAX), ordered by most recent decision date.
View allOther Clearances by Parker Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Aug 15, 2024 | Substantially Equivalent |
| K953673 | ECLIPSE PROBE COVER | Mar 14, 1996 | Substantially Equivalent |
| K921695 | ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS | Feb 23, 1995 | Substantially Equivalent |
| K864556 | AQUALUBE(TM) | Dec 1, 1986 | Substantially Equivalent |
| K861239 | ACRYLIC SOLDER | Apr 17, 1986 | Substantially Equivalent |
| K855167 | DYNA SYSTEM | Mar 4, 1986 | Substantially Equivalent |
| K851895 | POLYGEL ULTRASOUND GEL | Sep 27, 1985 | Substantially Equivalent |
| K852956 | CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION | Aug 9, 1985 | Substantially Equivalent |
| K841400 | NEURO PULSE | Jun 15, 1984 | Substantially Equivalent |
| K840548 | RESIL | Apr 17, 1984 | Substantially Equivalent |