FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
O. B. PACK III
K Number: K902273
·
Decision Aug 21, 1990
Classifications
1
FEI Numbers
307
Registration Numbers
307
Same Product Code
135
Applicant Total
36
Review Days
92
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Basic Information
- Device Name
- O. B. PACK III
- K Number
- K902273
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Customed, Inc.
- Date Received
- May 21, 1990
- Decision Date
- August 21, 1990
- Product Code
- HHD
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HHD | Pad, Menstrual, Unscented | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHD), ordered by most recent decision date.
ALWAYS MENSTRUAL PADS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ALWAYS DUETS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ENVIVE MINIFORMS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
UNSCENTED INTERLABIAL MENSTRUAL PAD
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FDA Class 1
·Obstetrics/Gynecology
GLADRAGS COTTON MENSTRUAL PAD
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Other Clearances by Customed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974647 | FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 | Jan 5, 1998 | Substantially Equivalent |
| K971920 | GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) | Dec 4, 1997 | Substantially Equivalent |
| K964011 | SUCTION CATHETER TRAY PRODUCT NO. 900277 | Nov 25, 1996 | Unknown |
| K962652 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) | Oct 4, 1996 | Substantially Equivalent |
| K962596 | CUSTOMED BLOOD EXTRACTION KIT | Sep 27, 1996 | Substantially Equivalent |
| K961442 | UNIVERSAL DRAINAGE TRAY | May 9, 1996 | Substantially Equivalent |
| K953678 | STERIMED STERIZATION WRAPPER (NON-STERILE) | Oct 2, 1995 | Substantially Equivalent |
| K950295 | WOUND CLOSURE/LACERATION TRAY | Apr 18, 1995 | Substantially Equivalent |
| K942177 | FOLEY CATHETERIZATION TRAY | Sep 8, 1994 | Substantially Equivalent |
| K925018 | IV PREP KIT W/O DRESSING (NON-STERILE) | Aug 27, 1993 | Unknown |