FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CERTI HEAT INSTANT HEAT COMPRESS
K Number: K940336
·
Decision Mar 7, 1994
Classifications
1
FEI Numbers
377
Registration Numbers
377
Same Product Code
81
Applicant Total
17
Review Days
41
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Basic Information
- Device Name
- CERTI HEAT INSTANT HEAT COMPRESS
- K Number
- K940336
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5710
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Certified Safety Mfg., Inc.
- Date Received
- January 25, 1994
- Decision Date
- March 7, 1994
- Product Code
- IMD
- 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 |
|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | FDA class 1 | Physical Medicine |
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Other Clearances by Certified Safety Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960587 | CPROTECTOR 2000 | Jul 21, 1997 | Substantially Equivalent |
| K960615 | GAUZE COMPRESS | Nov 25, 1996 | Substantially Equivalent for Some Indications |
| K960624 | CERTI COOL INSTANT COLD COMPRESS | May 6, 1996 | Substantially Equivalent for Some Indications |
| K953102 | BLOODBORNE PATHOGEN KIT | Dec 11, 1995 | Substantially Equivalent |
| K946338 | CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING | Mar 29, 1995 | Substantially Equivalent |
| K945004 | 2, 3 & 4 BANDADGE COMPRESS | Mar 22, 1995 | Substantially Equivalent |
| K945002 | 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE | Mar 22, 1995 | Substantially Equivalent |
| K940249 | CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING | Oct 3, 1994 | Unknown |
| K941311 | FIRST AID/TRUMA KIT | Jun 14, 1994 | Substantially Equivalent |
| K940358 | X-LARGE MULTI-FUNCTION TRAUMA DRESSING | Mar 23, 1994 | Substantially Equivalent |