510(k) K970530
- Device
- ANSPACH LUBRICATING SYSTEM II
- Applicant
- The Anspach Effort, Inc.
- 510(k) number
- K970530
- Product code
- GEY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-05-05
- Date received
- 1997-02-12
- Regulation
- 878.4820
- Classification name
- Motor, Surgical Instrument, Ac-Powered
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM E ANSPACH III, MD
- Address
- 4500 Riverside Dr. Palm Beach Gardens FL US 33410 33410
FDA Registration Numbers#
- 3006985163
- 3016214537
- 1526439
- 3018940271
- 8030607
- 3003244954
- 2020550
- 3009730286
- 9616024
- 3003120897
- 3021907852
- 3008910197
- 3024788684
- 3015967359
- 1226544
- 2245304
- 3033509898
- 3025603301
- 2085947
- 3009217531
- 3016172274
- 1828288
- 3034676720
- 3007997036
- 3005064037
- 3011534620
- 1000655211
- 1526534
- 1219602
- 3010097171
- 2183744
- 3010232390
- 2032809
- 9611253
- 8043750
- 9614446
- 3016050940
- 8010177
- 9611102
- 2916714
- 2081135
- 3006017180
- 3014479313
- 3022320321
- 3018094310
- 3011300255
- 3014342096
- 3015399803
- 1836161
- 3017056829
- 3009039068
- 3009417901
- 3008110533
- 3002807310
- 3013493300
- 1000655158
- 3014586728
- 3007279848
- 3015376465
- 3015724777
- 1822565
- 3027728872
- 1043653
- 3010202439
- 3013055499
- 3004142400
- 3021851820
- 3017410090
- 1818910
- 3007305485
- 3015504568
- 9615659
- 3008812560
- 3004464325
- 3014579188
- 3018318562
- 2032098
- 1045834
- 3007958831
- 9617840
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050519 | ADVANCED TURBO DRIVE SYSTEM | Linvatec Corp. | 2005-05-17 |
| K020621 | ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS | Arthrocare Corp. | 2002-03-28 |
| K012738 | SYMPHONY GRAFT DELIVERY SYSTEM (GDS) | Depuyacromed | 2001-11-14 |
| K972308 | MEDNEXT 1000 DRILL | Mednext, Inc. | 1997-08-20 |
| K971941 | AQUA SPRAY | Boyd Industries, Inc. | 1997-08-14 |
| K971782 | BONE AND MARROW COLLECTION SYSTEM KIT | Biomedical Ent., Inc. | 1997-07-29 |
| K971268 | BONE & MARROW CLLECTION SYSTEM | Biomedical International Corp. | 1997-07-03 |
| K964252 | ORTHOCHUCK | Buckman Co., Inc. | 1997-05-27 |
| K964073 | BME BONE DRILL BITS | Biomedical Ent., Inc. | 1996-11-14 |
| K962789 | SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM | Smith & Nephew Endoscopy, Inc. | 1996-08-14 |
| K961901 | BONE & MARROW COLLECTION SYSTEM | Biomedical Ent., Inc. | 1996-08-06 |
| K954470 | SURGIMOTOR | W.O.M. World of Medicine GmbH | 1995-12-08 |
| K951773 | PODOSPRAY DRILL SYSTEM | Darco Intl., Inc. | 1995-10-26 |
| K952008 | KARL STORZ DRILL | KARL STORZ Endoscopy-America, Inc. | 1995-07-26 |
| K951118 | 3M MAXI-DRIVER II ELECTRIC SYSTEM | 3M Company | 1995-07-06 |