FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DC PACK TM
K Number: K821134
·
Decision Jun 22, 1982
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
10
Applicant Total
5
Review Days
63
Basic Information
- Device Name
- DC PACK TM
- K Number
- K821134
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1050
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- SEAMLESS HOSPITAL PRODUCTS CO.
- Date Received
- April 20, 1982
- Decision Date
- June 22, 1982
- Product Code
- HFC
- 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 |
|---|---|---|---|
| HFC | Aspirator, Endocervical | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFC), ordered by most recent decision date.
ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CERVICAL MUCOUS ASPIRATION CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PEDI VAGINAL ASPIRATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SELECTMUCUS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ENDOCERVICAL ASPIRATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
O. B. PACK IV
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by SEAMLESS HOSPITAL PRODUCTS CO.
| K Number | Device Name | ||
|---|---|---|---|
| K841769 | INTERMITTENT URETHRAL CATHETER TRAY | Aug 24, 1984 | Substantially Equivalent |
| K823061 | BRUSH, SCRUB, OPERATING ROOM | Nov 5, 1982 | Substantially Equivalent |
| K820490 | IV START TRAY | Mar 16, 1982 | Substantially Equivalent |
| K781127 | CONNECTING TUBE, CONDUCTIVE, SURG. | Sep 20, 1978 | Substantially Equivalent |