510(k) K964634
- Device
- ANOKRYO
- Applicant
- MK CONQUEST INTL., INC.
- 510(k) number
- K964634
- Product code
- FFP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-06-06
- Date received
- 1996-11-19
- Regulation
- 876.5450
- Classification name
- Dilator, Rectal
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD A HAMER
- Address
- 100 E. 15th St.,Suite 320 Fort Worth TX US 76102 76102
FDA Registration Numbers#
- 3030726486
- 3011137372
- 3004215929
- 3017087293
- 3004443374
- 3012477715
- 1421879
- 1061124
- 9612278
- 1836161
- 8040278
- 3010041511
- 1522875
- 3011630465
- 9681622
- 2916714
- 3003431869
- 3008770252
- 3008797953
- 3008338766
- 1315756
- 3043355002
- 3004111573
- 1643817
- 3001644167
- 3004550973
- 1423537
- 3008388437
- 9616088
- 3010399422
- 3042277215
- 3010526986
- 8030607
- 1216677
- 3005630901
- 3031984
- 3002769835
- 3005528784
- 3009888344
- 3008808049
- 3005921952
- 3015183635
- 3016965929
- 3005833605
- 1222274
Source Documents#
Other 510(k) Records For Product Code FFP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K901426 | COLONIC BALLOON DILATOR | Telemed Systems, Inc. | 1990-06-21 |
| K894618 | INAMED RHEMO-D (TM) DILATOR | Inamed Development Co. | 1990-01-18 |
| K884713 | COLONIC BALLOON DIALATORS | Primrose Medical, Inc. | 1989-09-29 |
| K830354 | COLORECTAL DILATOR | Cleveland Medical Supply & Services | 1983-05-27 |
Legacy Summary#
summary
FDA Review#
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