510(k) K936255
- Device
- Custom Cv Pack
- Applicant
- ASSOCIATED MEDICAL
- 510(k) number
- K936255
- Product code
- KDD
- Decision
- Substantially Equivalent for Some Indications (SN)
- Decision date
- 1994-03-31
- Date received
- 1993-12-30
- Regulation
- 878.4800
- Classification name
- Kit, Surgical Instrument, Disposable
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SCOTT WIEST
- Address
- 11140 Bren Rd., W. Minnetonka MN US 55343 55343
FDA Registration Numbers#
- 1423537
- 1526611
- 3014457631
- 3028002947
- 3013756169
- 3039169546
- 3014257280
- 1423395
- 3014644369
- 1047843
- 2936485
- 2433012
- 3015895045
- 3006098219
- 3008467060
- 1054241
- 2245304
- 1928237
- 3013307971
- 8010273
- 1032347
- 1219930
- 1220477
- 3010273872
- 1422598
- 3023339277
- 3004598675
- 3007597038
- 3002807115
- 3027807601
- 2530138
- 3015416207
- 3016248648
- 1820334
- 3010536692
- 2135156
- 9612030
- 1061124
- 3012187635
- 3016733629
- 3005440795
- 1935627
- 3008338766
- 2320762
- 3010659131
- 3005675811
- 3003431869
- 3029082594
- 3002807310
- 1054811
- 3015745029
- 1424263
- 3013002167
- 3004892425
- 3004125670
- 3016874083
- 9614841
- 3001084743
- 3007139365
- 3008559295
- 1043534
- 3006554788
- 3010052483
- 3031184338
- 2032098
- 3008676146
- 3004464325
- 2531684
- 3005669815
- 3010610950
- 3008902714
- 3010370474
- 3010060157
- 3011525245
- 1030451
- 8020785
- 8044099
- 3007697249
- 3017461134
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KDD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072814 | CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES | Covidien | 2008-04-16 |
| K011514 | INSTRUMENTS FOR ONE TIME USE - DISPOSABLE | Kencap , Ltd. | 2001-08-13 |
| K971317 | NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS | National Healthcare Mfg. Corp. | 1997-05-08 |
| K960456 | DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY | Denver Biomaterials, Inc. | 1996-04-01 |
| K932219 | SUTURE SET OR LACERATION TRAYS (PACKS) | Associated Medical Products Co. | 1993-07-09 |
| K923176 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | 1993-06-17 |
| K925905 | KIT, SURGICAL INSTRUMENT, DISPOSABLE | Kay Medical Concepts | 1993-06-16 |
| K924958 | BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY | Medical Insights, Inc. | 1993-06-07 |
| K925215 | STERILE SURGICAL INSTRUMENT TRAYS | American Healthcare Supply Co., Inc. | 1993-06-01 |
| K924117 | DEXIDE LAPAROSCOPIC KITS | Dexide, Inc. | 1993-03-23 |
| K920989 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | 1992-10-19 |
| K920763 | LACERATTION TRAY | Sterile Concepts, Inc. | 1992-09-28 |
| K920516 | GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB | Trinity Laboratories, Inc. | 1992-04-16 |
| K914244 | STERILE CUSTOM SURGICAL KITS | Ulti-Med Intl., Inc. | 1992-02-24 |
| K913049 | SLIP-PRUF-CLINGER | Macbrud Corp. Medical Div. | 1991-09-11 |