510(k) K852105
- Device
- MANAN UBK ULTRASONIC GUIDED BIOPSY KIT
- Applicant
- MANAN MANUFACTURING CO., INC.
- 510(k) number
- K852105
- Product code
- FCH
- Decision
- Substantially Equivalent - With Drug (SESD)
- Decision date
- 1985-06-18
- Date received
- 1985-05-15
- Regulation
- 876.4730
- Classification name
- Tray, Biopsy, Without Biopsy Instruments
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MANFRED MITTERMEIER
- Address
- 8020 N. Central Park Ave. Skokie IL US 60076 60076
FDA Registration Numbers#
- 3005440795
- 1047429
- 3010230734
- 3005595283
- 3044182936
- 1928237
- 8040278
- 3008492462
- 2183446
- 1420054
- 2433012
- 1123010
- 3015173212
- 3004111573
- 1030451
- 1423395
- 3035642068
- 3009558349
- 3004122598
- 2029015
- 1528319
- 2531475
- 2027804
- 3005012805
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FCH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K882673 | SIGMA 1 WOBBLER BIOPSY KIT | Kontron Instruments, Inc. | 1988-07-28 |
Legacy Summary#
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FDA Review#
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