The following data is part of a premarket notification filed by The Silcraft Corp. with the FDA for Silcraft Access 3700 Whirlpool System, Silcraft Model 1800 Lift, Silcraft Disinfectant.
| Device ID | K971593 |
| 510k Number | K971593 |
| Device Name: | SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT |
| Classification | Bath, Hydro-massage |
| Applicant | THE SILCRAFT CORP. 555 THIRTEENTH ST., N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein THE SILCRAFT CORP. 555 THIRTEENTH ST., N.W. Washington, DC 20004 -1109 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-01 |
| Decision Date | 1998-02-26 |
| Summary: | summary |