The following data is part of a premarket notification filed by Aqua Care Corp. with the FDA for Whirlpool Bathing Unit-#2001.
| Device ID | K802335 |
| 510k Number | K802335 |
| Device Name: | WHIRLPOOL BATHING UNIT-#2001 |
| Classification | Bath, Hydro-massage |
| Applicant | AQUA CARE CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-23 |
| Decision Date | 1980-10-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866595000234 | K802335 | 000 |
| 00866595000227 | K802335 | 000 |
| 00866595000210 | K802335 | 000 |
| 00866595000203 | K802335 | 000 |