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#
- 3043620689
- 3003528228
- 3015859709
- 1222773
- 9681465
- 1721504
- 3043648115
- 2433012
- 1221934
- 3008559295
- 3008676146
- 3030067857
- 3003477135
- 3016874083
- 3008338766
- 3006554788
- 3007329020
- 3014644369
- 3014314985
- 3014457631
- 3015895045
- 3017952668
- 3039169546
- 3033796310
- 3011585752
- 1211566
- 3016195240
- 3018094310
- 1000614268
- 1043214
- 3007139365
- 3011280379
- 1061927
- 1225691
- 3006638824
- 9617229
- 3010060157
- 3006098219
- 3010470577
- 3009340886
- 3006946102
- 3004111573
- 1643116
- 3017538679
- 2531684
- 1313525
- 3016171914
- 3013307971
- 3006128100
- 3001084743
- 8044099
- 3011680076
- 1824619
- 3006460162
- 3013666218
- 3015143057
- 3011525245
- 2025182
- 3010155661
- 3036756245
- 1211998
- 1420054
- 3004513970
- 3003960560
- 3009495876
- 3004638532
- 3003431869
- 3010583458
- 3045816902
- 3003597504
- 1718873
- 3038220293
- 3004125670
- 3008132398
- 3004365956
- 3005034064
- 3023191945
- 3016068274
- 1038671
- 1048735
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 |