FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERA-PAK
K Number: K780452
·
Decision Jun 21, 1978
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
92
Applicant Total
13
Review Days
92
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Basic Information
- Device Name
- THERA-PAK
- K Number
- K780452
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Hydro-Med Products, Inc.
- Date Received
- March 21, 1978
- Decision Date
- June 21, 1978
- Product Code
- ILO
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | FDA class 2 | Physical Medicine |
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Other Clearances by Hydro-Med Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944198 | SURGICAL MICROSCOPE DRAPE | Nov 27, 1994 | Substantially Equivalent |
| K940151 | ULTRASOUND PROBE DRAPE | Nov 14, 1994 | Substantially Equivalent |
| K934630 | UNIVERSAL VIDEO/LASER ARM DRAPE | Oct 28, 1994 | Substantially Equivalent |
| K940152 | CAMERA COVER WITH TEAR TIP | Oct 28, 1994 | Substantially Equivalent |
| K923099 | X-RAY DRAPES | Oct 15, 1992 | Substantially Equivalent |
| K863872 | TAMPER HAMPER | Feb 10, 1987 | Substantially Equivalent |
| K853281 | EASYTOP | Aug 21, 1985 | Substantially Equivalent |
| K842304 | THE PATHFINDER | Aug 1, 1984 | Substantially Equivalent |
| K834407 | STERILE DISPOSABLE SPINAL NEEDLES | Mar 19, 1984 | Substantially Equivalent |
| K812405 | STERILE TV CAMERA & CORD COVER | Oct 20, 1981 | Substantially Equivalent |